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Quality - QA Specialist

Company: Net2Source
Location: New Brunswick
Posted on: November 25, 2022

Job Description:

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.

Title: QA Specialist
Duration: 12 months
Location: New Brunswick, NJ

Pay- $43.08/hr on w2

Job Description:
This role is an 18 to 24 month opportunity to gain experience with Bulk Drug Substance manufacturing. The Senior Quality Assurance Specialist will provide Quality oversight to the CMO with the ability to be on site up to support Quality Reviews and QA Shop Floor manufacturing support. You will manage CMO oversight for change management, deviation management, Annual Product Quality reports, Quality Agreements, Risk Assessments and CMO product release. This position may also be cross trained to cover other QA functions as needed.

Responsibilities:
--- Provides oversight for CMO Batch Production Records. Reviews executed Batch Records, GMP documents and prepare documentation for product release/disposition.
--- Assists with Document Control and other QA functions.
--- Coordinates and assist in timely review of documentation associated with manufacturing at CMO site.
--- Assists with preparation for FDA and other regulatory agency audits and inspections. Provides daily summaries and follows the completion of CAPAs from audit findings.
--- Gives guidance to CMO as needed and ensure CMO is compliant with Client Quality standards.
--- Ensures that all audit items are resolved. Supports site for Inspection. Reviews any Quality Events, CAPAs from internal and external audits to ensure that actions necessary to provide adequate confidence that the cGMP requirements are completed on time.
--- Escalates critical quality problems to Senior Management in a timely manner.

Qualifications
--- BS in Life Sciences or equivalent with 5+ years related experience within a pharmaceutical or Biotechnology Company.
--- Hands-on QA Site or ExM Operations / QA Systems experience including supporting Validations within pharmaceutical or Biotechnology Company. Must be fluent in English language.
--- Additional experience in an area allied with cGMP Quality, Quality Systems, Biopharma Production Processes, 21CFR 210-211, ICH guidelines, FDA Guidance for Industry for Investigating OOS Results, Deviations, CAPAs, Validation, Stability Studies, QC laboratory operations and manufacturing operations, auditing is preferred.
--- Ability to Coordinate Quality oversight and working with other site groups.
--- Ability to review Quality documents and ensuring compliance to GMP. Documents to include batch records, logs, and others.
--- Ability to be an effective communicator to Management, and line staff.
--- Ability to work with other manufacturing teams to implement business objectives.
--- Must be very detail oriented and be able to quickly detect errors within documentation.

Additional Job Requirements:
None

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)

Regards
Recruiter name
Designation
Office: (201) 340-8700 x XXX - Cell: (201) xxx xxxx - Fax: (201) 221-8131- Email:

Keywords: Net2Source, New Brunswick , Quality - QA Specialist, Other , New Brunswick, New Jersey

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