QLTY ASSURANCE METHODS / QA METHODS MGMT - QUALITY MANAGER - Net2Source
New Brusnswick, NJ 08903
About the Job
Net 2 Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap Right Talent Right Time Right Place Right Price and acting as a Career Coach to our consultants.
Position Title: Quality Manager Quality Assurance Methods Management
Duration: 12 months
Location: New Brunswick, NJ 08903
Pay Rate $ 45.00/hr on W2
Work Schedule- Normal business hours
Job Functions:
Provides Quality and Compliance oversight to Contract Manufacturing and Packaging Organizations (CMOs) within a cross-functional team and Product Disposition functionality for drug products manufactured by CMOs. Primary responsibility is to ensure that the CMOs are operating in compliance with all Client and applicable Food and Drug Administration (FDA) and international regulatory standards. In addition, this position has responsibility to ensure that released products comply with Client internal and government (FDA or specific market) requirements and support Quality Services processes (e.g., complaint investigations and change controls).
Responsibilities:
1. Manages CMO relationships from a quality and compliance perspective, including monitoring quality metrics, performing annual risk assessment of CMOs and executing oversight as defined by Standard Operating Procedures (SOP's), authoring and executing Risk Mitigation Plans as needed
2. Determines disposition of drug products according to CLIENT and regulatory specifications and standards
3. Review change requests generated internally or by External Manufacturer
4. Reviews Annual Product Quality Reviews (APQR's) authored by Contract Manufacturers/Packagers and supplement APQR's as required
5. Investigate and/or evaluate manufacturing, packaging and laboratory deviations or incidents and associated Corrective and Preventive Actions (CAPA's) and provide direction and recommendations as to future course(s) of action
6. Review Quality Agreements
7. Review and approve product quality complaint investigations
8. Review and approve validation/qualification protocols and reports from the External Manufacturer as defined in related Quality Agreements
9. Write, review and implement SOP's to ensure compliance with current CLIENT standard and current Good Manufacturing Practices (cGMP)
10. Participate as required on Fact Finding Investigation Team (FIT and Fact Finding Investigation Review Meetings (FIRM)
11. Supports product recalls and executes plan as assigned
12. Represent Client during FDA/other regulatory inspections and corporate GMP compliance audits as defined in related Quality Agreements
13. Assist with preparation of audit observations
14. Participate in audits (For Cause) of North American External Manufacturers of drug products ensuring compliance with all appropriate CLIENT and FDA and European Medicines Agency (EMA) cGMP regulations and policies
15. Represent Quality on cross-functional teams within the "Virtual Manufacturing Plant ", Technical Transfer teams, Supplier Selection, Serialization Manufacturing and Packaging launch teams
Required Competencies;
1. Knowledge in solid dosage forms, parenteral technology, biologics or combination products
2. Knowledge of compendial and cGMP requirements, FDA regulations and the ability to interpret and apply them
3. Proficiency with the use of global systems (e.g., Systems, Applications and Products (SAP), Document Control and Archiving (DCA)).
4. Good verbal and written communication skills essential
5. Excellent interpersonal skills
6. Capable to manage multiple priorities
7. Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met
8. Trained in auditing techniques and skills such as observation, questioning, and assessment of complex problems
Required Qualification(s) and Desired Experience;
1. B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent
2. A minimum of five (5) years' experience in pharmaceutical, biologics, biotech or related industry with relevant experience
3. Experience in a Quality Assurance, Quality Control or equivalent function is required
4. Experience in the manufacture of drug substance and/or drug product or quality control laboratories is desired
CLIENT Biopharma Behaviors
The qualified candidate demonstrates characteristics of our CLIENT BioPharma Behaviors. For more details, refer to InSite CLIENT Website/ People and Performance/ CLIENT BioPharma Behaviors.
Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit in with an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand out with opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management, and beyond.
Equal Employment Opportunity Statement:
Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law.
Awards and Accolades:
America's Most Honored Businesses (Top 10%)
Awarded by USPAAC for Fastest Growing Business in the US
12th Fastest-Growing Staffing Company in the USA by Staffing Industry Analysts in the US (2020, 2019, 2020)
Fastest 50 by NJ Biz (2020, 2019, 2020)
INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% of companies make it to this list).
Top 100 by Dallas Business Journal (2020 and 2019)
Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
2019 Spirit of Alliance Award by Agile1
2018 Best of the Best Platinum Award by Agile1
2018 TechServe Alliance Excellence Awards Winner
2017 Best of the Best Gold Award by Agile1(Act1 Group)
#LSC1
Position Title: Quality Manager Quality Assurance Methods Management
Duration: 12 months
Location: New Brunswick, NJ 08903
Pay Rate $ 45.00/hr on W2
Work Schedule- Normal business hours
Job Functions:
Provides Quality and Compliance oversight to Contract Manufacturing and Packaging Organizations (CMOs) within a cross-functional team and Product Disposition functionality for drug products manufactured by CMOs. Primary responsibility is to ensure that the CMOs are operating in compliance with all Client and applicable Food and Drug Administration (FDA) and international regulatory standards. In addition, this position has responsibility to ensure that released products comply with Client internal and government (FDA or specific market) requirements and support Quality Services processes (e.g., complaint investigations and change controls).
Responsibilities:
1. Manages CMO relationships from a quality and compliance perspective, including monitoring quality metrics, performing annual risk assessment of CMOs and executing oversight as defined by Standard Operating Procedures (SOP's), authoring and executing Risk Mitigation Plans as needed
2. Determines disposition of drug products according to CLIENT and regulatory specifications and standards
3. Review change requests generated internally or by External Manufacturer
4. Reviews Annual Product Quality Reviews (APQR's) authored by Contract Manufacturers/Packagers and supplement APQR's as required
5. Investigate and/or evaluate manufacturing, packaging and laboratory deviations or incidents and associated Corrective and Preventive Actions (CAPA's) and provide direction and recommendations as to future course(s) of action
6. Review Quality Agreements
7. Review and approve product quality complaint investigations
8. Review and approve validation/qualification protocols and reports from the External Manufacturer as defined in related Quality Agreements
9. Write, review and implement SOP's to ensure compliance with current CLIENT standard and current Good Manufacturing Practices (cGMP)
10. Participate as required on Fact Finding Investigation Team (FIT and Fact Finding Investigation Review Meetings (FIRM)
11. Supports product recalls and executes plan as assigned
12. Represent Client during FDA/other regulatory inspections and corporate GMP compliance audits as defined in related Quality Agreements
13. Assist with preparation of audit observations
14. Participate in audits (For Cause) of North American External Manufacturers of drug products ensuring compliance with all appropriate CLIENT and FDA and European Medicines Agency (EMA) cGMP regulations and policies
15. Represent Quality on cross-functional teams within the "Virtual Manufacturing Plant ", Technical Transfer teams, Supplier Selection, Serialization Manufacturing and Packaging launch teams
Required Competencies;
1. Knowledge in solid dosage forms, parenteral technology, biologics or combination products
2. Knowledge of compendial and cGMP requirements, FDA regulations and the ability to interpret and apply them
3. Proficiency with the use of global systems (e.g., Systems, Applications and Products (SAP), Document Control and Archiving (DCA)).
4. Good verbal and written communication skills essential
5. Excellent interpersonal skills
6. Capable to manage multiple priorities
7. Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met
8. Trained in auditing techniques and skills such as observation, questioning, and assessment of complex problems
Required Qualification(s) and Desired Experience;
1. B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent
2. A minimum of five (5) years' experience in pharmaceutical, biologics, biotech or related industry with relevant experience
3. Experience in a Quality Assurance, Quality Control or equivalent function is required
4. Experience in the manufacture of drug substance and/or drug product or quality control laboratories is desired
CLIENT Biopharma Behaviors
The qualified candidate demonstrates characteristics of our CLIENT BioPharma Behaviors. For more details, refer to InSite CLIENT Website/ People and Performance/ CLIENT BioPharma Behaviors.
Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit in with an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand out with opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management, and beyond.
Equal Employment Opportunity Statement:
Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law.
Awards and Accolades:
America's Most Honored Businesses (Top 10%)
Awarded by USPAAC for Fastest Growing Business in the US
12th Fastest-Growing Staffing Company in the USA by Staffing Industry Analysts in the US (2020, 2019, 2020)
Fastest 50 by NJ Biz (2020, 2019, 2020)
INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% of companies make it to this list).
Top 100 by Dallas Business Journal (2020 and 2019)
Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
2019 Spirit of Alliance Award by Agile1
2018 Best of the Best Platinum Award by Agile1
2018 TechServe Alliance Excellence Awards Winner
2017 Best of the Best Gold Award by Agile1(Act1 Group)
#LSC1
Source : Net2Source