Overview
Skills
Job Details
Position Summary:
The Quality Assurance (QA) team is seeking a highly motivated and detail-oriented Senior Associate, Quality Assurance, to support manufacturing operations. The Senior Associate will perform routine QA functions including batch record review, raw material disposition, deviation management, CAPA, change controls, and QA support for manufacturing. This role requires onsite presence and participation in a fast-paced, dynamic environment.
Additional Details:
Contract Length: 12 Months contract position
Pay range: $40 to $ 48/hour on W2 as per your experience
Key Responsibilities:
- Review and approve executed electronic batch record comments; partner with manufacturing personnel to resolve discrepancies.
- Review and approve test results; perform LIMS review and issue Certificates of Analysis (COAs) as required.
- Provide QA oversight and support for cleanroom manufacturing activities.
- Serve as a QA point-of-contact for escalations, troubleshooting, and operational triage.
- Perform hands-on QA activities such as intake of patient apheresis and drug product pack-out.
- Compile, review, and approve lot disposition records.
- Execute raw material disposition and approve raw material specifications.
- Review and approve deviations, change controls, CAPAs, excursions, and nonconformance records.
- Promote and reinforce a culture of safety and GMP compliance.
- Identify continuous improvement opportunities within QA and manufacturing processes.
- Support complex change controls and qualification/validation activities, including protocol and report review.
- Conduct internal audits (as applicable).
- Support operational excellence initiatives.
Qualifications:
- Experience in clinical or cGMP manufacturing environments.
- Proficiency with electronic Quality Management Systems (eQMS) including deviations, CAPAs, and change management.
- Strong organizational, analytical, and problem-solving skills.
- Excellent communication, interpersonal, and cross-functional collaboration abilities.
- Ability to work independently and in a team, manage priorities, and meet deadlines.
- Adaptability and comfort in a fast-paced, start-up-like environment.
- Strong scientific and technical understanding.
Education:
- BS degree in a relevant scientific field (biochemistry, chemical engineering, bioengineering, or related).
Must be authorized to work in the United States.
Pride Health offers eligible employee s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.
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About Us
Russell Tobin is a leading minority-owned professional and technical recruitment and staffing advisory organization.
We are comprised of specialized practices focusing on a variety of skill sets and industries. Having a depth and breadth of industry expertise, our subject matter experts are able to provide tailored and swift sourcing solutions to fulfill client hiring needs. In other words, we connect top talent with companies.
We are the staffing arm of the Pride Global network, a minority-owned integrated human capital solutions firm, with additional offerings in vendor management, payroll programs, and business process optimization.
As a certified minority-owned business, Pride Global and its affiliates - including Russell Tobin, Pride Health, and Pride Now - are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics.
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