Location: Hummelstown, PA
Company: Reaction Biology
Finding these answers is our mission as a CRO. Our method is to accelerate the drug discovery process with the widest possible range of assays and services but also to maintain an integrated view of the journey to a lead drug candidate. We strive to provide excellent data, delivered in a timely, collaborative manner by outstanding scientists.
Come join our team! Position Summary: The Quality Assurance Manager is an onsite position out of Hummelstown, PA. They're responsible for ensuring that the company's products meet quality standards and regulations. Also, they're responsible for creating and enforcing the quality standards, procedures, and policies for the company. They work with
the QA team on testing and quality standards, but they also work with employees in general to ensure they understand the quality standards that are required throughout the process.
Quality Assurance Managers stay on top of the latest laws and regulations that impact products. They handle data related to quality to analyze the company's performance as well as quality reports and documentation that are required as part of the QA procedures. Main Responsibilities: Plans, coordinates, and directs quality assurance programs proactively and helps establish standards designed to ensure continuous data quality. Reviews and evaluates inputs related to the Quality Management System for compliance,
trends, effectiveness, and conformance to industry standards as well as applicable international/regulatory requirements.
Review processes and systems on an ongoing basis to determine where improvements can be made; works with operations to revise / establish procedures, standards, and systems. Directly supervise the site Quality Team including the selection and development of people, resources, and budgets necessary to perform the functions of the department; trains workforce as required in various quality methods, standards, and procedures. Conduct announced and unannounced audits for both GLP and non-GLP studies (in vitro and in vivo) to ensure operations are on the highest quality level as well as lead the site internal audit program.
Perform review and data verification of reports for GLP and non-GLP studies, including Study Plans/Protocols, study reports, and ancillary records. Lead SOP management/review cycles along with associated training as well as administer site deviation, CAPA, and change management processes. Ensure training program in place for staff training on procedures introduced by new and revised SOPs, including on-going refresher training as well as OECD Principles of GLP and in compliance with 21CFR58. Monitor care and use of animals to ensure activities are conducted in accordance with the principles outlined in the Guide for the Care and Use of Laboratory Animals, 8th Edition, 2011 (National Research Council) and to ensure compliance with approved IACUC protocols.
Ensure DEA license is kept current via updates and annual renewal and ensure periodic inventory of controlled substances is conducted. Key Qualifications: BS/BSc degree (MS or greater preferred) in relevant scientific field 7+ years of progressive quality assurance background with direct GLP / ISO experience preferred. At least 3+ years prior experience managing and executing internal site audit programs.
Direct experience managing an e QMS system. Working knowledge of KPI's, GLP/ISO requirements, Six Sigma and Lean Manufacturing.
The ideal candidate for Asphalt QC Lead should have a positive attitude, have excellent communication skills, be innovative, and promote change to improve the quality, efficiency, and cohesion of the Asphalt QC Department. Candidates should be able to use advanced technical skills and methods to improve quality, process control, customer experience, and performance, train new and existing employees, and troubleshoot.
The Asphalt QC Lead will be mobile and responsible for activities at all Central Pennsy locations and job sites. Essential Duties and Responsibilities Ensure a safe work environment in compliance with all safety policies and procedures using the appropriate tools and equipment
for the task. Adhere to and follow all safety rules and regulations of MSHA/OSHA/DOT and Pennsy Supply, Inc. Collaborate with RMC and Agg QC Managers and Leads Lead by example to promote teamwork among QC and other stakeholders.
Evaluate data for deviations or trends away from accepted standards. Schedule lab and field staff Increase leadership presence and aid in accountability to internal and DOT QC Plans Assist technical staff with troubleshooting, drive corrective action, and escalate issues to necessary stakeholders across all Pennsy central locations. Monitor Daily logs, identify risks, and assist with the timely management of data. Assist with lab and field coverage as needed.
Communicate with customers, build relationships with internal and external customers.
Always participate in knowledge transfer Prepare project submittals and attend pre-placement meetings. Cross-train within the department and other LOBs Participate in leadership training. Other tasks as assigned by the HMA QC Manager, as well as HMA and Managers Become proficient in the use of Command QC and Mix optimization tools. Monitor trends in strengths and identify areas of opportunity and risk. Set up and perform trial batches, R&D Update and maintain mix designs at Asphalt plants, including material changes, mass updates, yield, and accuracy. Assist in the development and implementation of industry-leading onboarding and training SOP.
Lead the effort in training new employees and assist in continued education for technical staff. Complete procedure audits on technical staff and provides coaching, assist in technical staff evaluations. Adhere to and promote high-level safety culture. Use and promote the use of all required PPE. Maintain an exemplary work environment and promote the practice of completing JSA’s, Risk Analysis, and Near Miss reporting. Recognize employees that demonstrate excellent safety behaviors. Lead Toolbox Talks Maintain inventory of PPE and safety equipment Attends meetings as required or directed.
Other duties as assigned. Requirements Must submit to a drug screen and criminal background check. Able to work various times during day, night or weekend hours. Education/Experience High School Diploma or GED equivalent. bachelor’s degree preferred Five years related experience and/or training; or equivalent combination of education and experience. preferred Penn DOT asphalt plant certified or related preferred. Must have a valid driver’s license. Must be able to work with customers and employees; have a teamwork attitude.
Excellent computer skills and proficiency in Word, Excel, Outlook, etc. Able to work various times during the day, night, or weekend hours, at various locations. Able to train and direct QC technicians. About Pennsy Supply Pennsy Supply operated in Pennsylvania as a family run business producing asphalt, aggregates, and concrete as well as providing construction services until joining the CRH family in 1993. With being a part of the CRH family they are now a proud reflection of the hundreds of family businesses, local and regional companies and mid to large sized enterprises that together form CRH.
CRH is the number one asphalt producer, the third-largest aggregates producer, and one of the top 5 ready mixed concrete producers in the Unites States. CRH operates with a decentralized, diversified structure, letting you work in a small company environment while having the career opportunities of a large enterprise. EOE / M / F / Vet /Disability What CRH Offers You Highly competitive base pay Comprehensive medical, dental and disability benefits programs Group retirement savings program Health and wellness programs A diverse and inclusive culture that values opportunity for growth, development, and internal promotion About CRH CRH has a long and proud heritage.
We are a collection of hundreds of family businesses, regional companies and large enterprises that together form the CRH family. CRH operates in a decentralized, diversified structure that allows you to work in a small company environment while having the career opportunities of large international organization. If you’re up for a rewarding challenge, we invite you to take the first step and apply today! Once you click apply now, you will be brought to our official employment application. Please complete your online profile and it will be sent to the hiring manager.
Our system allows you to view and track your status 24 hours a day. Thank you for your interest! Pennsy Supply, a CRH Company, is an Affirmative Action and Equal Opportunity Employer. EOE/Vet/Disability--If you want to know more, please click on this link.
and the customer Qualifications Required - Bachelor of Science degree in Mechanical Engineering or related four-year degree with equivalent experience Requires ability to use personal computer and various measuring devices Requires ability to read, understand, and interpret blue prints Requires ability to read, understand, and interpret quality measurement data Knowledge of various quality control procedures and practices including statistical process control Five years' experience in related quality management position Firsthand experience with ISO certification and maintenance Essential functions and responsibilities - Design all process control procedures by department to assure consistent
performance in production and delivery of products Train or assist in the training of all personnel in proper performance of duties to be consistent w/ established quality procedures Develop quality trend reporting data to enable individuals to suggest or implement continuous improvement opportunities Report on a monthly basis all quality trends and problems Develop and/or maintain programs to promote communication of quality standards & problem solving through employee training Monitor and survey the quality of incoming purchased materials and recommend quality improvements Audit current quality systems to backss their effectiveness and accuracy Maintain Quality Manual and related process documents
to conform with latest ISO9001:2015 standards Ability to lead a team to establish root cause of a quality issue Assist in performing audits and surveys of vendor's performance Assist as needed in process/engineering problem solving Maintain and/or establish ISO procedures Job Posted by Applicant Pro
a field role. Job Location: Havertown, PA Responsibilities/Duties: Report to the field to perform, inspect, and/or oversee fieldwork Oversee and review work of personnel, subcontractors and consultants to ensure compliance with approved plans and acceptable tolerances Ensure that appropriate and required testing is completed by qualified personnel using properly calibrated equipment Assure compliance with contract requirements and thoroughly understand the measurement & payment of each item of work With Project Controls support, ensure prompt preparation of the work progress estimates and track pay quantity records and maintain proper documentation Evaluate, review, monitor and document results
and help make necessary decisions/ adjustments to procedures Consult and collaborate work with Project Manager, Superintendent, as well as Health and Safety, Quality Control, Project Controls, Estimating, and Contracts representatives to ensure work is conducted according to approved plans, GES standards, regulatory criteria, and contractual obligations Plan, prepare and issue project and field submittals within approved budget including but not limited to various QC reports Apply industry standards of practice for selected technology, adhering to regulatory codes and standards, national/ local standards, and company SOPs Participates in team project meetings Education/Experience: This position
requires a Bachelor's degree in Engineering, Engineering Management or related field from an accredited institution.
This includes a minimum of: 32 college semester credit hours of higher mathematics and basic sciences; and 48 college semester credit hours of engineering science and/or engineering design courses Equivalent combination of education and experience may be substituted for this requirement. Engineering, quality, or environmental credential (e. g. EIT, CQA, EPI) - or - PE license or ability to attain during tenure in this position HAZWOPER 40 Hour Certification with current 8 Hour Refresher USACE Contractor Quality Management for Contractors certification A minimum of 3-6 years of experience required; two years or more of progressively responsible experience performing field QC on environmental remediation or hazardous waste management projects Benefits: Paid holidays Vacation/PTO Medical, dental and vision insurance Life and Accident Insurance 401K Plan EQM conducts pre-employment drug screens and pre-employment physicals.
EQM is an equal opportunity employer (EEO). This employer participates in e-verify. Job Posted by Applicant Pro
approval, material receiving, internal audit process ad document control. Requires experience in ISO-9001/ISO 13485 or c GMP manufacturing environment plus demonstrated familiarity with standard quality concepts. 2.0 Supervisory Responsibilities: None. 3.0 Position Requirements: Note: Qualifications are based upon education, resume and/or work experience.
3.1 Minimum of 3 years of experience. 3.2 Possess a great attention to detail. 3.3 Must be able to work independently with minimal direction or oversight. 3.4 Must be able to maintain accurate and organized records. 3.5 Windows-based computer skills, familiarity with Microsoft Word and Excel. 3.6 Good organizational skills with ability
to manage multiple priorities. 4.0 Responsibilities include (but are not limited to): 4.1 Must be able to take a leadership role in Quality related decisions. 4.2 Proactively ensure batch records are reviewed prior to material release, ensuring paperwork is completed accurately, neatly and fully.
4.3 Performs through root cause analysis and establishes in-depth and robust corrective and preventative actions for both internal non-conformances and customer complaints. 4.4 backsses materials received against internal procedures and performs the necessary approval to release materials. 4.5 Ability to read unplanned deviations, change controls, validations and other technical documents/reports
to identify errors and/or potential non-compliance issues and to backss potential product/process risk.
4.6 Complete supplier approval paperwork for new incoming suppliers 4.7 Participate in internal audits and inspections including planning for audits, execution, and follow-up on audit findings. 4.8 Assists in the tracking and maintenance of document control activities. 4.9 Write, revise and review standard operating procedures (SOPs) and custom specifications. 4.10 Become thoroughly knowledgeable of the applicable SOPs and maintain that knowledge base. 4.11 Other duties as assigned 5.0 Education: 5.1 4 year college degree in quality/compliance related field or science-related field with 2-4 years related experience.
6.0 Physical Requirements: 6.1 Prolonged periods of sitting at a desk and working on a computer. 6.2 Must be able to lift up to 25 pounds at a time. 6.3 Must be able to access and navigate each department at the organization's facilities. 7.0 Working Conditions: 7.1 Conditions inside the office is generally quiet, periodically there may be mid-level noise from various equipment when traveling to other facilities.
while coordinating activities with other IT groups The QA Analyst’s primary focus is ensuring accurate functionality of the food production applications based on business requirements. The analyst will perform and organize group testing, then manage all correspondence with development team to ensure accurate functionality of new product features.
Job Responsibilities Performing unit and regression Testing to ensure existing functionality in food production application is not compromised by new development. Creation of test scripts and management/reporting of test results of new application functionality to proper teams Completion of post-production testing after deployment of code to
production to ensure these basic functions work so that no interruptions occur to application users. Usability Testing – Organizing and Managing User Acceptance Testing.
Individual will create UAT test scripts appropriate for user group. They will track documentation and feedback to review both internally and with consultant group Direct communication with offshore development team to improve use case understanding and improve overall development process Communication and management of change requests. Documentation and review of these change requests to be able to communicate level of effort and scope impact. Acceptance testing software to confirm software satisfies all requirements
documented in the user story. Maintains strong working knowledge of the business area and the applications that support it.
Develops a basic understanding of the industry and the products and services of Aramark. Has a solid understanding of how systems effect and benefit clients (end users Must have extensive in-depth experience with Food Production applications and Procurement systems. Must have some experience within food services operations and experience working with software applications that support the operations Resource will report directly to Application Development IT Manager Must be detailed oriented to document and track all types of testing results, resolutions, and communication to appropriate team members.
Must have solid communication skills to present testing plans and results to appropriate groups. Demonstrates an understanding of the changing business needs for the lines-of-businesses and the impact these changes have on the technology and information necessary for exceptional service and growth. Proactive in the search for improvement opportunity and the identification of potential business impediments. Identify solution, document features and process and assist in implementation of the solution to improve user experience. Qualifications Must have extensive in-depth experience with Food Production applications and Procurement systems.
Must have some experience within food services operations and experience working with software applications that support the operations Resource will report directly to Application Development IT Manager Must be detailed oriented to document and track all types of testing results, resolutions, and communication to appropriate team members. Must have solid communication skills to present testing plans and results to appropriate groups. Demonstrates an understanding of the changing business needs for the lines-of-businesses and the impact these changes have on the technology and information necessary for exceptional service and growth.
Proactive in the search for improvement opportunity and the identification of potential business impediments. Identify solution, document features and process and assist in implementation of the solution to improve user experience. Education Bachelors preferred About Aramark Our Mission Rooted in service and united by our purpose, we strive to do great things for each other, our partners, our communities, and our planet. At Aramark, we believe that every employee should enjoy equal employment opportunity and be free to participate in all aspects of the company.
We do not discriminate on the basis of race, color, religion, national origin, age, interaction, gender, pregnancy, disability, interactionual orientation, gender identity, genetic information, military status, protected veteran status or other characteristics protected by applicable law. About Aramark The people of Aramark proudly serve millions of guests every day through food, facilities, and uniform services in 19 countries around the world. Rooted in service and united by our purpose, we strive to do great things for each other, our partners, our communities, and our planet.
We believe a career should develop your talents, fuel your passions, and empower your professional growth. So, no matter what you're pursuing - a new challenge, a sense of belonging, or just a great place to work - our focus is helping you reach your full potential. Learn more about working here at http: // or connect with us on Facebook , Instagram and Twitter.
GLPQA will report to the Sr Director GLPQA and will be responsible for developing the GLP Quality Framework. The AD will support all GLP/GCLP activities, provide assurance to the company that GLP studies and clinical sample assays are done in compliance with all applicable regulatory requirements, company policies/ SOPs, and GLP/OECD guidelines.
Responsibilities Drive the direction, development, implementation and execution of the GLP Quality Framework, and GCLP processes, systems, tools, training, etc. Liaise and align with other applicable GXP (e. g. GMP, GCP, etc. ) Quality Assurance teams to ensure coordination and compliance with overall Spark Quality Systems. Initiate and drive
compliance support of the GLP stakeholders (immunology, translational research, PCO, etc. ) and their activities through GLP/GCLP regulations along with quality process and related consultancy, advice and training.
Will monitor by developing, tracking and reporting compliance metrics. Create and manage comprehensive GLP Audit Programs. Manage the conduct of GLP/GCLP audits of GLP studies/assays, assays of clinical samples (GCLP), and CROs used by Spark to ensure regulatory compliance. Serves as the Lead in the coordination, preparation for and management of GLP related inspections by Regulatory Authorities (including pre-inspection activities as well as follow-up activities) Communicates
to senior management of critical issues, coordinates the preparation of data trending metrics for reporting into Sr Management.
Interact with GLP/GCLP stakeholders to promote continuous improvement programs through the analysis of these data. Oversee the maintenance and continued process improvements and operational excellence of GLP Standard Operating Procedures and Policies. Train and mentor GLP-QA team members Manager Third -Party GLP Vendors ensuring appropriate allocation and utilization of contracted GLP resources, globally. Maintain in depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to GLP/GCLP Quality Assurance activities.
Education and Experience Requirements BS in Scientific Discipline/ Life Sciences or related discipline Minimum of 10+ years of medical industry experience with at least 7 years experience in GLP Quality Assurance with other relevant GXP experience, preferred. Experience with OECD regulations. Very good knowledge of GLPs, GDPs, quality systems, and GXP auditing required. Must have good expertise in GLP regulations, international regulations/guidelines, and have the ability to understand, interpret and apply applicable regulations Domestic travel up to 25% Key Skills, Abilities, and Competencies Strong leadership and communication skills with special emphasis on collaboration skills.
Ability to think strategically and to quickly analyze complex circumstances and problems, and to drive appropriate decisions and actions. Very good prioritization, organizational, and communication skills Very good written and verbal communication skills in English Ability to motivate, develop, and inspire both his/ her team members and cross functional business partners Good computer skills Very good interpersonal skills, i. e. ability to build constructive relationships across all levels of the organization, positive & constructive attitude, and ability to work in interdisciplinary teams Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees.
The base salary range for this position is currently from $139,000 to $208,400. Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates.
Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.
dressings, sauces, mayonnaises, and other food solutions that exceed peoples’ expectations for great-tasting flavors and high-quality ingredients. Headquartered in Brea, California, Ventura Foods operates 14 manufacturing facilities, 3 culinary centers, and numerous distribution centers across North America.
When you work in our manufacturing and distribution facilities, you get a strong foundation of training, a manager who cares about you and celebrates your success, a safe environment, and challenging work. As part of our team, your future is limited only by how much you’re willing to push yourself to get there. We invest in your growth, because you invest in ours. Position Summary:
Under direct supervision, perform a variety of routine laboratory tests or other laboratory work to help provide top quality and safe products that meet customer requirements and specifications.
Assist plant operations personnel with quality and processing questions. Major Duties and Responsibilities: Under direct supervision, perform a variety of routine laboratory tests or other laboratory work to help provide top quality and safe products that meet customer requirements and specifications. Assist plant operations personnel with quality and processing questions. Education and Experience: High School Diploma/GED or equivalent experience 1 year of experience Manufacturing lab environment
experience preferred Knowledge and Skills: Chemistry training Good math, problem solving, and organizational skills Effective written and verbal communication skills Ability to work with minimum supervision and be a self-starter Excellent teamwork and good interpersonal skills, with the ability to interact well with others at all levels Physical Demands: Regularly requires intermittent sitting, standing, walking, climbing, squatting, kneeling, pushing, and pulling.
Physical strength and dexterity sufficient to perform the required task(s). Must occasionally lift and/or move up to 50 pounds or more with assistance. Additional demands may be required. Work Environment: In addition to normal business hours, work schedules may include after hours and weekends as needed.
May work outside and in adverse temperatures which include extreme hot, cold, and humidity. May be exposed to fumes or airborne particles, toxic or caustic chemicals and vibration. Must be willing and able to wear personal protective equipment as required by established Company Safety standards. May require work in confined and dark spaces, and at heights in excess of 18 feet for prolonged periods of time. Diversity & Inclusion: Our commitment to a diverse and inclusive environment in which all employees are treated with respect is evident in our company culture and values.
We believe that fostering an environment of inclusion and a focus on diversity across our organization is vital to attracting top talent, driving innovation, and meeting the high expectations of our customers in a rapidly evolving global marketplace. Ventura Foods is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.
