Pharma/Manufacturing - Quality Assurance Specialist - Net2Source
Warren, NJ 07059
About the Job
Net2Source 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.
Job Title: QA Specialist
Duration: 06 months
Location: Warren, NJ 07059
Payrate: $ 36.50/hr on W2 (Paid Weekly)
PURPOSE AND SCOPE OF POSITION:
Location: Warren--Onsite
Local Candidates Only
Work Schedule: Mon - Fri, Business Hours
*Flexibility is key as needs of the business require extended hours and/or weekends as needed*
PURPOSE AND SCOPE OF POSITION:
Specialist, QA Operations, is responsible for quality oversight of Cell Therapy Development Operations (CTDO) activities in accordance with BMS policies, standards, procedures, and Global cGMP requirements. This position reports to the Senior Manager of Quality Assurance Operations.
Functional responsibilities include On-Site coverage of and/or participation in:
• QA Shop Floor and Warehouse/Storage Area Walkthrough activities
• Label Printing and Issuance of finished drug product and shipping labels
• Event Triage
• Packout oversight and performance of release-to-market
• Ensuring accurate and timely review, as well as maintaining, clinical manufacturing GMP/batch related
documentation and procedures.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
• BS/MS in a related scientific discipline.
• Minimum 4 years of experience within QA functions in the pharmaceutical industry.
• Thorough knowledge of cGMP in the pharmaceutical industry. Good understanding of the drug development
process.
• Knowledge and application experience with batch record review, product disposition/release, change control,
SOP review, GMP inspection.
• Good computer skills and working knowledge of common business software.
• Excellent organizational skills.
• Excellent problem-solving, verbal, and written communication skills.
• Must have strong interpersonal and communication skills, be a team player.
• Must be an individual with proven initiative and demonstrated accountability.
• Professional integrity and maturity are required.
DUTIES AND RESPONSIBILITIES:
• Provide Functional QA Oversight of Warren Manufacturing Operations, Supply Chain Operations, Warehouse,
QA and QC Laboratory processes in the execution of Clinical Manufacturing of Cell Therapy Products
• Participate in Shop Floor and Quality Check Walkthrough programs.
• Printing, Issuance, Chain of Identify (COI) verification, and Reconciliation of finished drug product labels used by
Manufacturing and Supply Chain Operations.
• Apply knowledge of quality processes, including batch record review, material disposition, triaging of deviations,
investigations, CAPA, risk management, change control, and product complaints.
• Revise department SOPs, as well as Review and QA Approval of CTDO SOPs
• Perform Real time review /approval of executed batch records and Chain of Identity verification.
• Responsible for ERP Material Status Changes of production/drug product
• Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and
requirements.
• Supports Risk Assessments/projects as required by senior management.
EDUCATION AND EXPERIENCE:
• B.S. scientific discipline or relevant college/ university degree preferred.
• Equivalent combination of education and experience acceptable.
• Strong knowledge of cGMP Quality and Compliance principles required.
• Clinical and Phase appropriate experience preferred.
• Strong cross-functional collaboration experience required.
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 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% 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)
Job Title: QA Specialist
Duration: 06 months
Location: Warren, NJ 07059
Payrate: $ 36.50/hr on W2 (Paid Weekly)
PURPOSE AND SCOPE OF POSITION:
Location: Warren--Onsite
Local Candidates Only
Work Schedule: Mon - Fri, Business Hours
*Flexibility is key as needs of the business require extended hours and/or weekends as needed*
PURPOSE AND SCOPE OF POSITION:
Specialist, QA Operations, is responsible for quality oversight of Cell Therapy Development Operations (CTDO) activities in accordance with BMS policies, standards, procedures, and Global cGMP requirements. This position reports to the Senior Manager of Quality Assurance Operations.
Functional responsibilities include On-Site coverage of and/or participation in:
• QA Shop Floor and Warehouse/Storage Area Walkthrough activities
• Label Printing and Issuance of finished drug product and shipping labels
• Event Triage
• Packout oversight and performance of release-to-market
• Ensuring accurate and timely review, as well as maintaining, clinical manufacturing GMP/batch related
documentation and procedures.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
• BS/MS in a related scientific discipline.
• Minimum 4 years of experience within QA functions in the pharmaceutical industry.
• Thorough knowledge of cGMP in the pharmaceutical industry. Good understanding of the drug development
process.
• Knowledge and application experience with batch record review, product disposition/release, change control,
SOP review, GMP inspection.
• Good computer skills and working knowledge of common business software.
• Excellent organizational skills.
• Excellent problem-solving, verbal, and written communication skills.
• Must have strong interpersonal and communication skills, be a team player.
• Must be an individual with proven initiative and demonstrated accountability.
• Professional integrity and maturity are required.
DUTIES AND RESPONSIBILITIES:
• Provide Functional QA Oversight of Warren Manufacturing Operations, Supply Chain Operations, Warehouse,
QA and QC Laboratory processes in the execution of Clinical Manufacturing of Cell Therapy Products
• Participate in Shop Floor and Quality Check Walkthrough programs.
• Printing, Issuance, Chain of Identify (COI) verification, and Reconciliation of finished drug product labels used by
Manufacturing and Supply Chain Operations.
• Apply knowledge of quality processes, including batch record review, material disposition, triaging of deviations,
investigations, CAPA, risk management, change control, and product complaints.
• Revise department SOPs, as well as Review and QA Approval of CTDO SOPs
• Perform Real time review /approval of executed batch records and Chain of Identity verification.
• Responsible for ERP Material Status Changes of production/drug product
• Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and
requirements.
• Supports Risk Assessments/projects as required by senior management.
EDUCATION AND EXPERIENCE:
• B.S. scientific discipline or relevant college/ university degree preferred.
• Equivalent combination of education and experience acceptable.
• Strong knowledge of cGMP Quality and Compliance principles required.
• Clinical and Phase appropriate experience preferred.
• Strong cross-functional collaboration experience required.
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 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% 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)
Source : Net2Source