on industry leading whey and milk protein isolates, concentrates, and hydrolysates. The animal nutrition division is a leading supplier of functional fats, proteins, and carbohydrates. The Quality Assurance Intern will be an active member of our quality assurance team but will interface with every aspect of the Milk Specialties Global Operations and Supply Chain while working in the manufacturing facility.
The trainee will be assigned duties that provide meaningful practical hands-on experience across the areas of quality assurance, operations, plant sanitation and the entirety of the supply chain. This is an excellent opportunity for a passionate, detailed oriented individual who thrives
in a nimble and fast-paced production environment. Essential Functions: Perform Analytical, Chemical, Physical and Organoleptic Testing on raw materials, in-process samples and/or finished products.
Calibration of equipment Package and prepare samples for shipment to third party testing locations Respond to internal calls to answer technical product questions Participation as a member of the plant safety team Attend all plant quality meetings Read and properly interpret documents such as, GMP manuals, HACCP programs and procedural manuals. Position Requirements: Bachelor's degree in food science, dairy science, chemical engineering, or biology preferred. Intermediate or advanced
with MS Office applications including Excel. Willingness to roll up sleeves and perform a variety of tasks necessary to support the organization.
Proven leadership skills. Strong analytical thinking skills and quick to acclimation to systems. Prior experience in manufacturing setting desired but not required.
have proficient analytical skills. Must have proficient problem-solving skills. Must have proficient multi-tasking skills. Must have proficient organizational skills. Must have above average interpersonal skills. Must be an excellent team player. Must have good judgment and decisiveness.
Must be reliable and prompt with all work activities and duties. Must have proficient Computer skills. Experience in USDA, FDA, CA Dept. of Food & Agriculture a plus. Experience in Kosher, Organic and AIB program a plus. Shall be neat, tidy, organized, and energetic. Ability to perform work duties under demanding and spur-of-the-moment working conditions. Must possess the ability to keep accurate daily,
weekly reports. Must be able to manage company confidential information. Must be self-motivated and have the ability to work with little or no supervision. Must be reliable, punctual and have schedule flexibility including working weekends, Holidays, and off-shifts as needed.
Must be able to comply with company attendance and punctuality policy. Must be able to fulfill essential job functions in a consistent state of alertness and safe manner. Must adhere to a drug and alcohol zero tolerance policy. Must be able to enforce, comply with and follow all food safety, and third-party certification policies (SQF, Gluten-Free and Organic, etc. ) Method of training: On-the-job training General
Job responsibilities Orientation and on the job Job Description Review Food Safety Practices & Policies (e.
g. HACCP, Food Safety, GMPs, Food Fraud/Defense, Allergens, Organic, Gluten Free)HACCP (Hazard Analysis Critical Control Points)Standard Operating Procedures (SOPs)Standard Sanitation Operating Procedures (SSOPs)Environmental Awareness Training Regulatory Agency Awareness (i. e. FDA)Product Quality Standards and Specifications Injury & Illness Prevention Program. Will receive general training and orientation that may include: 1. Company rules and regulations. 2. Plant Safety and Emergency Procedures 3. OSHA Required Safety Programs Essential Functions/ Duties and Responsibilities: 1.
Always performs tasks according to Safety and Food Safety Standards. 2. Maintains QA and R&D Manager informed of all activities, which impinge on Quality Assurance and production issues. 3. Assists in the company Metal Detection Program. 4. Assists with the Weight Control Program. 5. Assists in enforcing GMPs. Reports deficiencies to department supervisors 6. Assist in managing and controlling R&D Testing, Recipes and Product Formulations. 7. Assists in controlling Product Specifications. 8. Inspects all incoming raw materials for compliance with company policies.
9. Conducts daily Preoperational Inspections (PRE-OP) when needed. 10. Assists with enforcing companys Hold and Release Program. 11. Assists with Pest Control Program. 12. Assists with Recall Program. 13. Assists with Quality Control/Assurance Processes and Procedures. 14. Assists with waste reduction program. 15. Must be familiar with the company line of products(AAM1) to recognize their different specifications and verify they are meeting quality and food safety standards. 16. Assists in training employees with QA and R&D procedures. 17. Promotes and reinforces a positive food safety culture throughout the plant.
18. Assists with product-handling requirements. 19. Assists with enforcing production floor policies and procedures. 20. Actively enforces housekeeping rules. 21. Assists with maintaining chemicals and all containers properly labeled. 22. Maintains a firm safety discipline and reports unsafe acts and conditions. 24. Assists in ensuring the proper use of materials; may offer feedback to employees on their proper use to avoid waste. 25. Maintains first-rate and meaningful QA reports and documentation. 26. May assist Production Department when and where required. 27.
Other duties as assigned. Location: Mi Rancho, Elk Grove, CA- On Site Travel Requirements: Less than 5% (example: trainings) Typical Working Conditions, Equipment Used, and Essential Physical Tasks: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 1. Continual bending, kneeling, squatting, stooping, reaching, pulling, pushing, and lifting up-to 35 lbs. 2. Exposed to cool, hot temperatures and noise.
3. Must be able to stand for long periods of time. 4. Temperatures ranging to very warm conditions. 5. Loud noises generated from equipment. This job description may not be complete and is subject to change at any time without notice.
Vacation at Hire Clean, Well-Organized, Safe Workspaces First Shift Hours Convenient Commute Times The ideal candidate for this position will be a highly motivated, capable individual who can work independently as well as in a team environment. Previous experience with manufacturing processes is required.
Previous Quality Assurance experience is helpful but will train the right person for this position. Full Job Description: Job Title: Quality Assurance Tech Plant 2 - Gerald Industries Non-Exempt Reports To: Quality Assurance Supervisor/Leader Job Summary The primary focus of the position is auditing in the quality department (Shipping, product audit, process audit, and incoming material
inspection). Education, Training, Skills and Licenses Required - Previous experience with manufacturing processes such as machining and assembly - Experience using quality tools such as calipers, micrometers, height gauge, etc.
- Ability to read blueprints, engineering specifications, test specifications, and bills of material - Proficiency with Microsoft Office (Excel, Word, Power Point, Access) - Capable of implementing manufacturing process corrective actions. - Excels at written, verbal, and nonverbal communication skills - Must embrace change and have a team-oriented personality - Must be able to work independently and multi-task - Previous experience in a quality assurance setting
preferred Essential Functions - Perform all duties required of the shipping audit, product audit, process audit, incoming inspection, and RMA roles as needed.
- Record audit results on a controlled form and in an electronic spreadsheet or database. - Provide immediate and unbiased feedback of audit results to the area lead/supervisor for corrective action and communication to the department. - Present a summary of findings to the Quality Assurance Supervisor daily through the quality team meeting. - Provide a summary of findings to the Quality Assurance Supervisor/Leader monthly through the spreadsheet. - Assist in any corrective, preventative or improvement actions as required.
- Investigate developing quality issues and communicate with Quality Assurance Supervisor/Leader. - Arrange containment and segregation of products affected by a quality problem. - Good attendance is required for this position. Marginal Functions - Assist quality department in duties such as, but not limited to, sorting activities, product testing, and rework activities as needed. - Other duties as assigned by the Quality Assurance Supervisor/Leader. - Provide feedback on the effectiveness of implemented corrective actions and departmental improvements. Equipment Used - Computer, quality gages, and manufacturing tools.
Work Environment This job operates in a manufacturing environment with no air conditioning and loud machine noises. Employee is required to wear safety glasses at all times. Physical Requirements The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is regularly required to stand for long periods at a time, use fingers and hands to feel, handle, grasp or manipulate objects, tools or controls, reach with arms above, level with, or below shoulder; the employee is frequently required to bend and twist at the neck and waist, walk, push, pull, lift or move up to 40 pounds; employee is occasionally required to sit, squat, climb, balance, stoop, kneel, crawl, talk or hear.
Specific vision abilities include close, distant, peripheral depth perception and the ability to adjust focus. EEO Statement Standard Machine, DEMA Engineering, Gerald Industries & Viking LLC, are reaffirming that they support a policy of non-discrimination for all employees and applicants for employment. All aspects of employment with these companies will be governed on the basis of merit, competence, and qualifications and will not be influenced in any manner by Race, Religion, interaction, Age, National Origin, Handicap, Veteran Status, interactionual Orientation, Gender Identity, or Genetic information.
It is the policy of Standard Machine, DEMA Engineering, Gerald Industries, and Viking LLC, that all employees should enjoy a work environment free from discrimination, including any form of harassment. Should you have any questions regarding this statement see Human Resources.
regressive testing & maintenance. Requirements: Bachelor's (or equivalent) in Computer Science, Computer Engineering, Information Systems or related field + 3 years experience in related role. Salary range = $87,932 to $97,308/year. EEO/AAE/V/D. recblid n0v0gb3pt4ptlmudcfxirze3l0x8p4 PDN-9ad1ce96-2ccd6-328eea310d01
and guides the implementation of new processes, procedures, and methods. Models appropriate behavior as exemplified in MLH Mission, Vision and Values. Education/Experience/Licensure Education/Formal Training Work Experience Credential/Licensure REQUIRED: Associates degree in Nursing Minimum of three years experience as a registered nurse with at least two years experience providing direct patient care in a home health or hospice program.
Current licensure as Registered nurse in state of Tennessee or compact license. PREFERRED: Bachelor’s degree in Nursing N/A N/A SUBSTITUTIONS ALLOWED: N/A N/A N/A Knowledge/Skills/Abilities Must be qualified by knowledge and experience to oversee the
services provided in the assigned department/business unit. Demonstrates knowledge of federal, state, and local regulations and industry standards related to patient care services provided.
Strong professional, organizational, and interpersonal skills required for effective and creative leadership in working with all levels of the organization. Ability to lead and motivate individuals and groups toward the accomplishment of organizational goals. Possesses good analytical and problem solving skills. Demonstrates a high level of organizational skills to establish and manage priorities and maintain follow-up. Demonstrates initiative, flexibility, integrity and diplomacy. Proficient in the
use of Microsoft applications (such as Word, Excel) and experience with database systems.
Ability to apply critical thinking skills to identify problems, research alternatives, and recommend solutions. Working knowledge of healthcare reimbursement or experience in a similar healthcare administrative role is preferred. Work will require ability to read, interpret, and apply regulatory guidelines. Key Job Responsibilities Regulatory/Accreditation Readiness Responsible for the coordination of accreditation and regulatory standards for the assigned area(s)/business unit. Establishes and implements processes to support ongoing compliance and survey readiness.
Collaborates with leadership and team members to meet accreditation and compliance goals and objectives. Coordinates compliance audits, survey visits/activities, and post-survey follow-up activities. Serves as a change agent to identify, report, and recommend opportunities for improvement in clinical processes and procedures. Reviews proposed clinical processes and/or practices to determine implications and whether a new/revised standard is practical or achievable. Evaluates availability and capability of resources and identifies barriers required to fulfill clinical practice standards. Guides and coordinates policy/practice review to ensure alignment with regulatory and accrediting standards, best practices, and evidence-based practice.
Medical Record Review & Data Reporting Performs supervisory review of patient backssment forms completed by the clinicians for compliance with payor and regulatory data elements. Ensures documentation is valid, complete, and consistent with these requirements. Monitors patient’s plan of care to ensure sufficient medical documentation meeting payor and regulatory guidelines. Researches and resolves problems that may impact reimbursement for services.
Collects and reports backssment data and plan-of-care documentation electronically to a centralized state data repository. Serve as primary contact with physicians/physician offices to collect clinical documentation consistent with regulatory and reimbursement guidelines. Stays current in CHAP, Medicare, State, and other payor and regulatory requirements related to services provided. Assists with evaluating the quality of care provided by comparing performance with national benchmarks; collaborates with the Director of Quality in the identification, implementation, action planning, and tracking of improvement activities.
Clinical Education Develops, delivers, or coordinates standardized clinical education programs to meet existing, new, and revised patient care standards, processes, and regulatory guidelines. Guides the implementation of new processes, procedures, and methods. Educates clinicians on appropriate documentation protocols for data collection and documentation. backsses and maintains documentation of staff training and competencies; conducts regular review of continuing education, licensure, and certifications to ensure qualifications are maintained. Supervisory Supervises staff members as assigned within the department.
Monitors Associate performance and clarifies work expectations, and assists with goal setting; promotes cooperation among individuals and groups. Develops and implements processes through orientation, training and education to ensure that the competence of all staff members is backssed, maintained, improved and demonstrated throughout their employment. Plans and schedules work ensuring distribution of assignments and adequate staffing based on workload and productivity standards. Physical Requirements The physical activities of this position may include climbing, pushing, standing, hearing, walking, reaching, grasping, kneeling, stooping, and repetitive motion.
Must have good balance and coordination. The physical requirements of this position are: light work - exerting up to 25 lbs. of force occasionally and/or up to 10 lbs. of force frequently. The Associate is required to have close visual acuity to perform an activity, such as preparing and analyzing data and figures; transcribing; viewing a computer terminal; or extensive reading. The conditions to which the Associate will be subject in this position: The Associate is not substantially exposed to adverse environmental conditions; job functions are typically performed under conditions such as those found in general office or administrative work.
service requirements. Follow practices and processes intended to provide safe products that comply with appropriate laws and regulations, meet the company quality standards. Follow and commit to safety and GMP (Good Manufacturing Practices). Develop knowledge of processes, equipment, materials and products.
Conduct routine quality inspections of semi-finished, finished, and/or printed product to ensure all products meet established specifications. Compare the physical characteristics of components, materials, equipment, and products to technical specifications to identify defects. Conduct tests, record results, prepare reports and communicate changes that should be made improve quality.
Assist in third party audits Collect and ship product samples to Corporate Quality as needed Assist in implementing corrective actions Create, maintain, and review quality documentation Analyze data and reports on SPC and machine capability Core Skills and Qualifications: The ideal candidate must possess all of the following: Six (6) months of experience inspecting and performing quality checks or ; Twelve (12) credit hours in quality technology or related concentration from an accredited school Excellent visual and color acuity Math skills to include simple addition, subtraction, multiplication and division Ability to learn quality standards and methodologies Ability to use computer to record
results and create reports Demonstration of minimum proficiency with the English language in order to ensure effective new hire training and on-going communications about safety and quality issues Preferred Skills and Qualifications : Experience using Microsoft Office, including the ability to create basic reports, documents, presentations and spreadsheets in MS Word, MS Excel, and MS Power Point SAP or Quality Management System experience Overview: Dart makes everyday products that give people the freedom to enjoy the food & drinks they love, wherever they are.
From to-go containers and dinnerware to tamper-evident food packaging and even the red Solo cup, Dart products have been keeping people on the go and having fun for more than 50 years.
Dart is a family-owned, family-focused company of 13,000 employees united by a shared set of values. Headquartered in Mason, MI, Dart has 30 locations in four countries. Benefits: Dart Container full-time employees enjoy great benefits, including medical, dental, vision, life insurance, 401(k) with company matching contributions, paid vacation, paid holidays, short-term disability, tuition assistance, product discounts and more. Dart Container is a drug-free workplace. Candidates are subject to a drug test (excluding THC/marijuana/cannabis) and background check at the time of offer.
THC testing ONLY when such testing is required by law. Dart Container is an equal opportunity employer and will consider all candidates for employment without regard to race, color, religion, interaction, national origin, age, interactionual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. /eeoaa/ If you have a disability and need an accommodation to access this website or for the application process, you should call Dart at (800) 545-xyz X Ext 3370 or email us at calls can be made by dialing 711 or the relay number for your state.
If you experience difficulty applying online, you may call (800) 545-xyz X Ext 3390 or email us at for assistance.
Joining us means joining a caring, responsible, and innovative company where more than 70,000 people lead the way to greener and smarter mobility, worldwide Primary Function: Performs Electrical/Electronic/Mechanical Testing for Single Car and Multi Car Testing Responsibilities: Support train testing of all electrical/electronic/mechanical systems.
Troubleshoot and correct problems as required. Perform continuity, voltage, and current checks on train systems wiring Perform Pneumatic and/or Hydraulic system functional testing Correctly document Test Reports and all associated paperwork Develop Test Procedures and Reports for all Systems based on engineering documentation, customer specifications,
Alstom and supplier information Analyze System faults and repetitive issues, provide feedback and implement solutions Interface with Engineering and Vendors alike to resolve issues Support all groups with Test technical expertise and knowledge Test, troubleshoot and correct wiring issues on various train networks such as Ethernet, LAN and CAN Bus Upload software in all systems components Requirements: Associate Degree in Electrical/Electronic related field preferred; advanced experience and/or Relative associated qualifications/training considered.
ie Military Minimum of 1-year relevant experience with increasing responsibilities Must have sound mechanical aptitude Must be a Team Player,
able to successfully interact with team members of all departments/groups Must be willing and able to travel and work overtime, odd hours, weekends and various shifts as required Must adhere to all safety requirements Must have a working knowledge and ability to read and understand Electrical and Mechanical schematics and drawings Must have a working knowledge and experience in use of Electronic equipment; Power Supplies, Voltage/Continuity/Current Meters, Data Recorders/Loggers, Gauges, etc Working knowledge and abilities to use Microsoft Excel/Power Point/Word Must pass a written test as necessary Salary: 50,000 - 60,000 Alstom is a global company where our people vision and values embrace Diversity and Inclusion (D&I).
Wherever we operate and across all our businesses, we want to create an inclusive culture in which diversity is welcomed and appreciated. By bringing together people from diverse backgrounds and giving everyone the opportunity to contribute with their knowledge, skills, experiences and perspectives, we also generate value for Alstom and its stakeholders. Employment at Alstom is based solely on a person's merit and qualifications directly related to professional competence. Alstom does not discriminate against any employee or applicant because of race, creed, colour, religion, gender, interactionual orientation, gender identity/expression, national origin, disability, age, genetic information, veteran status, marital status, pregnancy or related condition (including breastfeeding), or any other basis protected by law.
It is Alstom's policy to comply with all applicable national, state and local laws pertaining to non-discrimination and equal opportunity. The Company's Equal Employment Opportunity (EEO) policy, as well as its affirmative action obligations, includes the full and complete support of the Company. Because it's just the right thing to do. We hope you think so, too.
come to life. Every day our products touch your life and the lives of people across the world, though you likely do not know it. Come join us and help us build The DNA of tech. ™ Where You'll Work & The Scope Vishay, Bennington, VT is currently seeking a full-time Quality Manager responsible for the efficient running of the Quality function within the Bennington, VT manufacturing location.
We’re looking for an experienced Quality Manager with strong supervisory and auditing skills. How You'll Help Us Build the DNA of Tech: Supervise Quality personnel in the performance of their job duties. Design and audit a control system that monitors the quality of the product; from design, purchase
and test of materials, process control, inspection and testing of the final product; to identify and record exceptions to the specifications desires. Manage total quality program Meet and deal with audit and survey individuals who may be in for source inspections, ISO90001 , MIL-STD-790 Negotiate new customer requirements Evaluate customer specifications for costing of inspection requirements as required by Engineering.
Initiate programs for documentation and control of the quality procedures and processes of the manufacturing operation. Perform vendor quality surveys. Direct and approve the product evaluation plan for the location. Initiate quality-training programs. Examine customer
quotation requests and specifications. Audit and analyze customer complaints and field reports.
Conduct customer surveys of company facilities regarding the location quality program. Experience You'll Need: Supervisory experience required 3+ years related quality engineering experience ISO 9001 and MIL-STD-790 knowledge highly beneficial Internal Auditor experience necessary Customer Complaint experience highly beneficial Excellent communication skills to deal effectively with employees at all levels in the organization, as well as outside individuals such as customers, source inspectors, auditors, etc. Experience with Export Compliance/ITAR preferred Knowledge of APQP and Core Tools Benefits: Health, Dental, & Vision Insurance 401(k) Paid Time Off Employee Assistance Programs Tuition Reimbursement This position requires access to information subject to the International Traffic in Arms Regulations and/or the Export Administration Regulations.
As such, this position is open only to applicants who qualify as “U. S. Persons” as defined by 22 C. F. R. §120.15 is required. “U. S. Person” includes U. S. Citizen, lawful permanent resident, refugee, or asylee. Vishay offers a comprehensive suite of benefit programs including health care coverage, financial support programs and other resources designed to help you achieve your personal and professional goals.
With us, you'll experience unique career paths, an open and collaborative culture, a stable business that will be there for you, and opportunities to work globally and locally. Do you have the skills we need? Are you ready to power your career as you power the world? If so, apply today. It is the policy of Vishay to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, interactionual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, Vishay is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact Opportunity Employer/Disabled/Veteran
to target DDR and be able to write Test Cases independently. -Should be able to understand the scope of the work and ask clarifications and escalate to the right leads in case of issues/delays- Should have advance SQL skills. Including complex PL/SQL coding skills.
- Should be able to navigate through Flat Files, Assist in UAT Testing- Should have prior experience working with Control-M/Powercenter. Equal Opportunity Employer Veterans/Disabled While an hourly range is posted for this position, an eventual hourly rate is determined by a comprehensive salary analysis which considers multiple factors including but not limited to: job-related knowledge, skills and qualifications, education
and experience as compared to others in the organization doing substantially similar work, if applicable, and market and business considerations. Benefits offered include medical, dental and vision benefits; dependent care flexible spending account; 401(k) plan; voluntary life/short term disability/whole life/term life/accident and critical illness coverage; employee assistance program; sick leave in accordance with regulation.
Benefits may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions. PDN-9acfb3db-bc6c-48a0-a434-8b2156a8df93
testing to validate functional and non-functional requirements for new software features. Build, maintain, leverage, and support scalable test infrastructure, automation framework, and CI/CD pipelines to maximize coverage, improve speed of delivery, and enable consistently high-quality results.
Create quality metrics, publishes reports, and drives goal-achieving improvements in software system quality and performance. Log, track, and report test-execution and defect-resolution status through completion. Certify monthly releases through end-to-end smoke, integration, regression, and performance testing prior to software deployment. Conduct peer code reviews. Telecommuting permitted. Minimum
requirements: Bachelors or foreign equivalent degree in Computer Science, Computer Information Systems, or a related field. Plus one year of experience in: Working in RDBM and No SQL database with Structured Query Language; Ensuring software application efficiency and reliability utilizing continuous integration and deployment (CI/CD) practices; Implementing and maintaining Web and API Automation Testing Framework and creating and executing test plans, test cases, and test scenarios, and generating report on test results; Testing APIs and web services utilizing tools such as Postman, REST Assured, or Soap UI; and Cloud integration testing for SAP CRM MDG, SAP ECC, SAP S/4 HANA, Azure and AWS.
In lieu of Bachelors or foreign equivalent degree in Computer Science, Computer Information Systems, or a related field, plus one year of experience as described above, employer will accept three years of experience in: Working in RDBM and No SQL database with Structured Query Language; Ensuring software application efficiency and reliability utilizing continuous integration and deployment (CI/CD) practices; Implementing and maintaining Web and API Automation Testing Framework and creating and executing test plans, test cases, and test scenarios, and generating report on test results; Testing APIs and web services utilizing tools such as Postman, REST Assured, or Soap UI; and Cloud integration testing for SAP CRM MDG, SAP ECC, SAP S/4 HANA, Azure and AWS.
Salary range: $125,000 - $155,000. Benefits: paid time off, medical/dental/vision/hearing aid/shop/behavioral health/employee assistance, health care reimbursement & dependent care assistance plans, short/long-term disability, AD&D, life insurance, 401(k), stock purchase plan. Job Order number must be indicated on your response. Please send resume to: Claudia Aguilera, JOB # 8341Costco Wholesale Corporation 999 Lake Drive Issaquah, WA 98027or xyz X@
both 21 CFR Part 212 and 211 (as needed) regulations. Apply quality assurance processes and procedures at the site level to ensure product quality and regulatory compliance. Write, review, approve, and implement procedures, specifications, processes, and methods as required.
Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications. Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications. Ensure that personnel is properly trained and
qualified. Ensure that the training is documented. Conduct periodic audits of the site to monitor compliance with established procedures and practices. May infrequently audit another site.
Liaise with internal and external inspectors and representatives, particularly on QA-related topics. Oversee the metrology program at the site (i. e. equipment, personnel qualifications, validations, etc. ). Ensure manufacturing and analytical equipment is appropriately maintained and calibrated. Ensure applicable facility certifications are maintained. Identify management problems in personnel, equipment, and the facility that requires correction. Review documents associated with the site's QA program
for completeness, errors, and omissions. A review executed CGMP records and product batch records to ensure compliance and product quality.
Review trends (e. g. environmental monitoring, deviations, facility issues, etc. ) to initiate corrective and preventive actions and/or for continuous process improvement. Conduct a continuous review of aseptic operations to ensure compliance to internal procedures (e. g. gowning, cleaning, sanitation, sterility, environmental monitoring, etc. ) and USP/FDA regulations. Ensure any deviations from normal procedures are documented and justified. Ensure an investigation is performed and documented when required, and corrective and preventative actions are taken (i.
e. follow and maintain corporate CAPA, deviation, and OOS protocols). Ensure compliance with all applicable standard operating procedures and regulations, including 21 CFR Part 212 (and 211 as needed) requirements. Ensure product complaints are handled in a manner consistent with Company SOPs and FDA regulations. Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions. Oversee the site-level change control process. Ensure that changes in the laboratory are accepted or rejected as appropriate, and ensure the changes are appropriately documented.
Attend quality and operational meetings. Interface with Corporate QA and Operations on quality-related issues. Provide status updates as required by management. Other responsibilities as required. Qualifications Bachelor's Degree (B. Sc. preferred. ) Experience and/or full knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing, and distribution of aseptic products preferred. Knowledge of USP, FDA, and c GMP regulations preferred. Knowledge of how and ability to write, review, and revise SOPs required.
Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, or technical procedures required. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required. Ability to write reports, business correspondence, and procedure manuals required. Ability to effectively present information, deliver training and respond to questions from groups of managers, clients, customers, and the general public required. Ability to define problems, collect data, establish facts and draw valid conclusions required.
Ability to solve problems and handle issues required. Proficient in MS Office applications required. Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required. Document Originator & Reviewer Approval Signatures PDN-9acfb3da-3e56-4ace-a40c-8e0edae50918
preferred. We offer an excellent salary and benefits package including relocation assistance, visa sponsorship if needed. About Us CPI, with more than 50 years experience, is the oldest provider of IP systems. We are also the largest provider of IP systems.
CPI has been under the same employee ownership since its founding in 1968. We are now owned and managed by two generations of CPI employees. CPI Cost and Quality Advantages CPI is and always has been debt free, and has no external stock holders, therefore, CPI's income is not drained to external investors but is used to improve products for you. This results in far superior products from CPI. CPI has the largest and highest quality
software development staff of over 60 professional IP system developers. This provides you with unique, cost effective IP products including: Annuity electronic data verification.
Delivery of patent office data to your patent system. Electronic patent audits providing fast, low cost data audit. System also finds missing cases. Valuable for due diligence and improving the accuracy of your patent database. IDS management system. recblid 02xtswdbr4ixokftalogrr46hm3mmx PDN-9acfcb78-37b4-4f1e-b3a8-ebb48fab3b1b
chemical and microbial tests. · Accurately record data and enter into database. · Appropriately approve or reject product following company policies. Product & Facility Inspections · Inspect production lines to verify product descriptions, product batch codes, product labels, product weights, metal detection, and case counts.
· Inspect end of day magnet and sifter tailings. · Perform end of day Radio and Knife Log Inspections. · Perform monthly GMP & Hygiene Inspections. · Perform monthly External Inspections. · Perform monthly Locker Inspections. · Perform quarterly and annual GBP Inspections. Laboratory · Perform calibration of laboratory equipment. · Perform environmental testing of
air plates, food contact and non-food contact swabs. · Perform proper sanitation of laboratory and equipment. · Follow proper microbial waste disposal procedures.
Records Review · Review Production & QC Records for completeness. · Verify accuracy of entered QC results. Food Safety, Quality & Legality Requirements · Comply with food safety, quality, and legal requirements. · Report any infractions of Food Safety, Quality or Legality to supervisor. · Follow personal hygiene practices as documented. OTHER JOB FUNCTIONS: Perform other duties as assigned. KNOWLEDGE, SKILLS, AND ABILITIES: Ability to follow written and verbal instructions. Detail oriented individual with a high level of accuracy.
Excellent organizational and communication skills. Time management and prioritization skills.
Flexible/adaptable to a fast-paced and fluid business environment. Proficient in the use of Microsoft Word and Excel. Ability to work as part of a team. EDUCATION: High School diploma or equivalent required. Relevant college coursework or Associate degree preferred. EXPERIENCE: At least one year of experience in Food Manufacturing Facility operation under a HACCP based quality program. POSITIONS SUPERVISED: None TOOLS/EQUIPMENT/MACHINES USED: Computer, scanner, and copy machine PHYSICAL REQUIREMENTS AND WORKING CONDITIONS: Normal office conditions apply. Employee must have clear, close vision for reading and computer work.
Must be able to sit, stand, walk, balance, stoop, grasp, talk, hear and operate computer keyboard. Job may require reaching at shoulder level and below waist. Will occasionally lift/push/pull up to 50 pound and carry objects.
