support of biodefense programs. The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biomedical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio through CMC, Nonclinical, Regulatory and Clinical activities consistent with Mapp's product development objectives.
The Director of Quality Assurance - GCP partners with Quality Assurance leadership to ensure synergistic alignment of Operations/Quality Assurance functions. Provides leadership for all Quality Assurance GCP related activities at the partner and CRO sites. Basic Qualifications BA/BS Degree
in a related Science; MS Degree in a related Science preferred 10+ Years of Development experience in a regulated medical industry with a significant amount of this time in a role that has GCP compliance expectations interacting with both Quality Assurance and clinical personnel Experience across all phases of biologic drug development (Clinical phases 1 thru 4 of drug development) Knowledge of drug development regulations such as the US and ICH GCP's Auditing of partner organizations Ability to effectively manage multiple projects to meet timelines, technical and GCP-quality requirements Maintains confidentiality Ability to work in teams with diverse cultural and professional backgrounds Travel
required (up to 20% domestic travel) Preferred Qualifications Experience working in a virtual biotech setting Large molecule and/or biologics experience Responsibilities Mapp Focused Reviews GCP protocols, GCP study reports, and Standard Operating Procedures to ensure GCP compliance and assists the Clinical team with GCP compliance for clinical activities Ensures deployment of the GCP-Quality Assurance strategy as approved by senior management Contributes to GCP maintenance of the quality system, as directed Reports all critical and relevant Quality compliance matters to the head of Quality Assurance Ensures required Quality Assurance expertise is available and effective for GCP study execution Ensures internal and external GCP audit programs are deployed and effective Ensures Quality Assurance review and approval/rejection of all GCP related procedures, documents and records Ensures, where appropriate, that all Mapp GCP related investigations, deviations, audit and critical documentation activities are complete and compliant to support GCP activities Ensures risk management principles, the essence of ICHQ10 and a continuous improvement culture are built into QA ways of working Ensuring deployment of Quality Strategy as approved by senior management Support deployment and implementation of HIPPA and Gx P's Collaborating with and supporting Operations leadership as well as Corporate leadership Acting as point of contact with regulatory authorities regarding issues at the partner and clinical trial sites, as well as (CRO's) Clinical Research Organizations Supporting the development and harmonization of quality standards and processes Establishing compliant policies, procedures and specifications Ensuring regulatory commitments are met on time and sustainability measures are in place Maintain good relationship with Regulatory bodies as well as Food and Drug Administration (FDA) inspectors Ensuring required Quality Assurance management and quality expertise is available and effective for operations Ensuring where appropriate that all Mapp personnel training, investigation, deviation actions, critical documentation and audit actions are completed on time Ensuring escalation to the Head of Quality Assurance and leadership of all critical concerns from sites related to product quality issues encountered at the CRO and partner's quality system Assists in constructing annual GCP training Leads or assists in authoring Clinical Standard Operating Procedures (SOP's) Acts as Gx P back-up for other members of Quality Assurance Partner Focused Influences a strong quality and compliance culture at the partner and contractor sites Acts as a SME on any QA-GCP issues at the partner sites Contributes as subject matter expert for matters relating to formal quality management and regulatory compliance at Mapp's partner clinical sites in collaboration with the Head of Quality Assurance Partners with key GCP customers on Quality system execution Acts as primary contact for discussions on GCP Quality matters with the clinical team, and key customers and contractors Acts as point of contact with regulatory authorities regarding issues at Clinical sites as needed Ensures GCP quality requirements are met Ensures enforcement of investigation of non-conformances, as well as fraud Ensures the Clinical sites are " audit ready" and compliant at all times Ensures, where appropriate, that all partner personnel training, investigation, deviation actions, critical documentation and audit actions are completed and compliant for GCP activities Writes GCP audit plans and other GCP-related documents Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job.
Mapp's anticipated pay scale for this position is $130,000 to $250,000 plus any applicable bonuses. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the candidate's level of education, and type and length of experience within the job and/or within the industry. Medical, dental, and vision insurance benefits are available to eligible employees and their families. Mapp also provides basic life insurance, short and long term disability, and a 401K plan that includes Company contributions to eligible employees.
Full time employees will be provided 7 days of sick time, 14 paid holidays, and will also accrue 18 days of vacation throughout the calendar year. If your job responsibilities allow, you may choose to work remotely. Willingness to Travel (Domestic Travel = Approximately 20%) will be required for this position. Mapp wants you to join their team and invites you to apply by submitting your information through mappbio. /jobs/. No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify. Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
Job Posted by Applicant Pro
strength and tightness.
Performs hydro testing and ballasting for ship alignment. Performs other related tasks as assigned, some of which may become essential to the position. Qualification Standards High school education/equivalent preferred.
Must have minimum two years of experience as a tank tester. Knowledge of a ship's arrangement and shipbuilding processes and procedures preferred. Must be able to recognize and avoid potential hazards, which are commonly present in the employee's work area. Must have ability to work at heights, in confined spaces, in all areas of the shipyard and be available to work any shift. Must comprehend written and verbal instructions and hear warning
signals, read and comprehend safety instructions, regulations and warnings. Essential Job Tasks Seal tanks and air test for tightness Perform hose test (air and water) for tightness Conduct hydro test for strength and tightness Operate of 700 GMP submersible pump Conduct vacuum box test Perform minimal weld and burn activities Maintain test procedure records Other tasks as may be assigned relevant to the trade Materials, Tools Equipment, Work Aids Works with various hand tools, power tools, welding and burning equipment test equipment, hoses and fittings.
Personal protective equipment required. Physical/Mental Involvement Frequent lifting, carrying up to 50 lbs. Pulling, standing, balancing,
walking, climbing ladders or equipment, reaching above shoulder or out in front, manual dexterity, pushing, kneeling, bending and stooping Works in all areas of the shipyard and on board ships.
Hearing warning signals and reading and comprehending safety instructions. Must be able to maintain general safety awareness and avoid hazard commonly present in employee's work area. Marginal Job Tasks Housekeeping in all work areas, including sweeping. May be required to attend safety, quality and/or process improvement meetings. Environmental Factorinteractionposure to fumes, odors, dust, gases, various climates and temperatures and low ventilation conditions, all of which can cause discomfort and/or respiratory difficulties.
Exposure to constantly moving machines and mechanical parts and high levels of constant noise. Payscale: $28.12 - $31.47This pay range is a reasonable estimate of the hourly range for this role. It takes into account the wide range of factors considered in making compensation decisions; including but not limited to skill sets, experience, training, and education. General Dynamics NASSCO also provides a variety of benefits including medical & dental insurance coverage, 401(k) retirement savings plan, flexible spending accounts/HSAs, life and disability insurance, company paid holidays and paid time off (PTO), wellness coaching, and an onsite health services.
General Dynamics NASSCO is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, national origin, disability, or veteran status, or any other basis protected by local, state, or federal law. To learn more about applicant rights under federal law, click here: EEO is the Law Poster EEO is the Law Supplement Pay Transparency If you have a disability that impacts your ability to complete the job application process and would like to request an accommodation, please contact our Human Resources Department.
Call (619) ###-#### or email.@. This contact information is for accommodation requests only, not to inquire about the status of applications. Nearest Major Market: San Diego Nearest Secondary Market: Job Segment: QA Tester, Security Clearance, Business Process, QA, Military, Quality, Government, Management Associated topics: active security clearance, m1 abrams tank, military, military intelligence, missile, navy, sco, sensor, sme, terrorism
and in support of biodefense programs. The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biomedical are responsible for the execution of high-quality Research and Development activities to ensure the achievement of a robust portfolio through CMC, Nonclinical, Regulatory, Project Management, and Clinical activities consistent with Mapp's product development objectives.
The Director of Quality Assurance - Gx P Analytical is an individual contributor who is a strategic thinking employee functioning as a key member of the Quality Assurance team who also partners with the CMC, Nonclinical, and Clinical development functions to ensure
data integrity and phase-appropriate compliance. Additionally, the Director of Quality Assurance - Gx P Analytical partners with Principal Investigators and the program teams to deliver on Mapp's portfolio.
Basic Qualifications BS/BA Degree in a related Science; MS Degree in related Science preferred 10+ Years of a combination of development experience in regulated medical roles, preferably within a Biologics/m Ab Product Development environment A significant amount of this time in a position that led or supported analytical and quality control operations for Drug Substance and Drug Product development and manufacturing Experience in a QA-Gx P role or a role that interacted with Quality
Assurance A solid background in analytical technologies and troubleshooting for large molecule products (preferably monoclonal antibodies) Strong background and in-depth knowledge in analytical chemistry across a wide range of technologies Demonstrated proficiency in method qualification, validation, stability programs and specifications setting and comprehensive understanding and significant experience in executing phase-appropriate qualification/validation strategies Excellent knowledge of c GMPs or equivalent regulations, e.
g. ICH, and the ability to interpret and relate Quality standards for implementation and review Experience in working with external parties (CDMOs, Contract Labs) Possesses the knowledge to act as a SME on any QA-Gx P data integrity issues Knowledge of drug development regulations such as the GCPs, GMPs and GLPs Willingness to travel required (up to 25% domestic and international) Previous technical CMC experience with large molecule (preferably monoclonal antibody) Drug Substance and/or Drug Product development/commercialization Previous experience with auditing biological and parenteral manufacturing facilities, laboratories that perform regulated activities, and/or clinical sites Experience overseeing Gx Ps (as a Sponsor) at third-party locations in a small or mid-sized Biotechnology company Preferred Qualifications MS Degree in related Science preferred Experience across all phases of biologic drug development (Clinical phases 1 thru 4 of drug development) preferred Experience in a technical or QA role for the oversight or execution of monoclonal antibody Drug Substance and Drug Product manufacture Experience working virtual preferred Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job.
Mapp's anticipated pay scale for this position is $130,000 to $250,000 plus any applicable bonuses.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the candidate's level of education, and type and length of experience within the job and/or within the industry. Medical, dental, and vision insurance benefits are available to eligible employees and their families. Mapp also provides basic life insurance, short and long term disability, and a 401K plan that includes Company contributions to eligible employees. Full-time employees will be provided 7 days of sick time, 14 paid holidays, and will also accrue 18 days of vacation throughout the calendar year.
If your job responsibilities allow, you may choose to work remotely. Willingness to Travel (Domestic Travel = Approximately Once per month + International Travel = Approximately Twice per year) will be required for this position. Mapp wants you to join their team and invites you to apply by submitting your information through mappbio. /jobs/. This job will remain open for twenty (20) days after being posted on Mapp's Job Openings website page (see link). No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law. Job Posted by Applicant Pro
of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self.
Become a maker of possible with us. As a Senior Quality Specialist at BD, you will be a key driver in ensuring the robustness and effectiveness of our Quality Management System. You will play a pivotal role in managing CAPA processes, conducting internal and external audits, integrating quality systems, and ensuring compliance with industry
regulations. Key Responsibilities: 1. CAPA Management: Lead and oversee the Corrective and Preventive Action (CAPA) process, from identification and investigation to implementation and effectiveness monitoring.
Ensure timely and effective resolution of quality issues. 2. Audit Coordination: Plan, conduct, and manage internal and external audits to evaluate the adherence to quality standards, regulations, and QMS procedures. Prepare audit reports, identify non-conformities, and guide corrective actions. 3. Quality System Integration: Collaborate with cross-functional teams to integrate quality management systems across various departments. Streamline processes, eliminate redundancies,
and ensure consistency in quality practices. 4. Regulatory Compliance: Stay up-to-date with relevant industry regulations and standards.
Ensure that the QMS remains in compliance and lead efforts to adapt to regulatory changes.5. Documentation Control: Oversee the management of QMS documentation and records, ensuring accuracy, version control, and compliance with document control procedures. 6. Continuous Improvement: Lead and participate in continuous improvement initiatives related to QMS processes, procedures, and quality standards. 7. Training and Development: Provide training and mentorship to junior quality specialists, ensuring their growth and development within the organization.
Qualifications: Bachelor's degree in a relevant field (e. g. Quality Management, Regulatory Affairs, Life Sciences). Minimum 7 years of experience in quality management with a focus on audits, quality system integration, CAPA and regulatory compliance. Strong knowledge of quality management principles, methodologies, and relevant regulations (e. g. FDA, ISO, GMP). Proficiency in CAPA software and auditing tools. (e. g. Trackwise)Demonstrated experience in leading and participating in internal and external audits. Excellent analytical, problem-solving, and communication skills.
Certification in Quality Management (e. g. Certified Quality Auditor) is a significant advantage. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work.
It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit /careers Becton, partinson and Company is an Equal Opportunity/Affirmative Action Employer.
We do not unlawfully discriminate on the basis of race, color, religion, age, interaction, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or interactionual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. PDN Primary Work Location USA CA - San Diego TC Bldg C&D Additional Locations Work Shift At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture.
We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed.
The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles. Salary Range Information $96,600.00 - $159,300.00 Apply Save Job Responsibilities Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. As a Senior Quality Specialist at BD, you will be a key driver in ensuring the robustness and effectiveness of our Quality Management System. You will play a pivotal role in managing CAPA processes, conducting internal and external audits, integrating quality systems, and ensuring compliance with industry regulations.
Key Responsibilities: 1. CAPA Management: Lead and oversee the Corrective and Preventive Action (CAPA) process, from identification and investigation to implementation and effectiveness monitoring. Ensure timely and effective resolution of quality issues. 2. Audit Coordination: Plan, conduct, and manage internal and external audits to evaluate the adherence to quality standards, regulations, and QMS procedures. Prepare audit reports, identify non-conformities, and guide corrective actions. 3. Quality System Integration: Collaborate with cross-functional teams to integrate quality management systems across various departments.
Streamline processes, eliminate redundancies, and ensure consistency in quality practices. 4. Regulatory Compliance: Stay up-to-date with relevant industry regulations and standards. Ensure that the QMS remains in compliance and lead efforts to adapt to regulatory changes.5. Documentation Control: Oversee the management of QMS documentation and records, ensuring accuracy, version control, and compliance with document control procedures. 6. Continuous Improvement: Lead and participate in continuous improvement initiatives related to QMS processes, procedures, and quality standards.
7. Training and Development: Provide training and mentorship to junior quality specialists, ensuring their growth and development within the organization. Qualifications: Bachelor's degree in a relevant field (e. g. Quality Management, Regulatory Affairs, Life Sciences). Minimum 7 years of experience in quality management with a focus on audits, quality system integration, CAPA and regulatory compliance. Strong knowledge of quality management principles, methodologies, and relevant regulations (e.
g. FDA, ISO, GMP). Proficiency in CAPA software and auditing tools. (e. g. Trackwise)Demonstrated experience in leading and participating in internal and external audits. Excellent analytical, problem-solving, and communication skills. Certification in Quality Management (e. g. Certified Quality Auditor) is a significant advantage. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health.
At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit /careers Becton, partinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, interaction, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or interactionual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
PDN Primary Work Location USA CA - San Diego TC Bldg C&D Additional Locations Work Shift At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility.
There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles. Salary Range Information $96,600.00 - $159,300.00 Apply Save Job PDN-9ae5d82b-81dd-4288-81af-7e78bad95c95
Atlantic Ocean, to stealth bombers, to landing on the moon. We look for people who have bold new ideas, courage and a pioneering spirit to join forces to invent the future, and have fun along the way. Our culture thrives on intellectual curiosity, cognitive diversity and bringing your whole self to work - and we have an insatiable drive to do what others think is impossible.
Our employees are not only part of history, they're making history. What you'll get to do: Sets up test apparatus and conducts tests of production assemblies and units following methods, procedures, standards, and sequences. Lays out and assembles units for production equipment according to designs and specifications.
Adjusts and calibrates systems as needed. Modifies equipment by adding, removing, or altering components as defined by predetermined diagrams and sketches. Corrects malfunctions by making adjustments or replacing parts or components as directed.
Uses hand and small power tools, and various measuring and testing devices in performing job duties. May monitor and verify quality in accordance with statistical process or other control procedures. Experience with laser cutting, laser welding, ribbon bonding, conformal coating masking & spraying, and x-ray apparatuses. Organized to implement new developments to manufacturing processes. Basic Qualifications: US citizenship and security clearance
High school diploma or GED and 4+ years of experience Experience working with test equipment such as oscilloscopes.
Ability to lift up to 30 pounds on a regular basis. Preferred Qualifications: Active top secret security clearance Mix of back shop and flightline maintenance experience Familiarity with Configuration Management and/or Mission Assurance concepts Salary Range: $57,800 - $96,300The above salary range represents a general guideline; however, Northrop Grumman considers a number of factors when determining base salary offers such as the scope and responsibilities of the position and the candidate's experience, education, skills and current market conditions.
Employees may be eligible for a discretionary bonus in addition to base pay. Annual bonuses are designed to reward individual contributions as well as allow employees to share in company results. Employees in Vice President or Director positions may be eligible for Long Term Incentives. In addition, Northrop Grumman provides a variety of benefits including health insurance coverage, life and disability insurance, savings plan, Company paid holidays and paid time off (PTO) for vacation and/or personal business. Northrop Grumman is committed to hiring and retaining a diverse workforce.
We are proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, interaction, interactionual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class. For our complete EEO/AA and Pay Transparency statement, please visit http: ///EEO. U. S. Citizenship is required for most positions. PDN-9adbc673-0c61-46ec-a2a3-df7deee1997e
in the development of Process Control Procedures (PCP) by conducting ship-checks, marking up and or creating system diagrams to meet the requirements of the Specification (Work Item). Will also perform other duties as assigned. Must reside in the Greater San Diego California Area, we are not looking to relocate candidates at this time.
Responsibilities: Trace shipboard systems and mark-up or create system diagrams as relating to flushing various shipboard system to reestablish cleanliness after industrial work has been accomplished also, will Attend meetings, checkpoints, review Objective Quality Evidence (OQE), submit reports, fill out forms and other duties as assigned. Qualifications:
Attention to detail Able to work various shifts and weekends Capable of conducting meetings with clients in a professional manner Perform basic mathematical calculations required for reports Able to read, understand and create Naval Ship System piping diagrams Ability to prepare Process Control Procedures (PCP) Previous experience working in the Flushing / Tank Cleaning Industry on Naval and Commercial Ships a plus.
Demonstrate good verbal and written communication skills Working knowledge of a computer, and able to utilize Microsoft Office Suite (Outlook, Word, etc. ) Ability to work independently Education Requirements: High school diploma, GED, Technical/Vocational trade school, or
apprenticeship. Working Conditions and Physical Demands: Able to perform the following activities: Climbing, Bending, Crawling, Accessing Confined Spaces, Walking Across Uneven Terrain, Working in Various Temperature Extremes, Wearing a Respirator and Safety Equipment Able to work at heights from Scaffold and Personnel Lifts Able and willing to follow all applicable site and company safety procedures Must be able to climb up and down ladders and gangways Ability to lift up to 50 pounds and carry the same for short distances and up and down stairs and steep inclines Other requirements: All positions require a pre-employment medical test.
This employer participates in E-Verify.
Must be able to qualify for DBIDS security clearance. Ability to read technical English is a must. U. S. Citizenship is required. Travel as needed. To respond to this ad, you: MUST provide us with a resume If all requirements listed above are not provided your application will not be considered. Please respond to this ad on our website: sbsbtc. /jobs/ Women, veterans and their spouses are encouraged to apply. We are an Equal Opportunity Employer. EEO/AA M/F D/V Job Type: Full-time Job Posted by Applicant Pro
