About the Role:
The Sr. Associate, Quality Assurance supports the Plant QA organization by providing daily oversight of Drug Product manufacturing areas. The ideal candidate is detail-oriented, a team player, and has prior Quality Assurance experience in a regulated environment.

Key Responsibilities:

• Maintain purposeful presence on the manufacturing floor, supporting inspections, ASP (Aseptic Simulation Process), and QA assessments.

• Perform electronic batch record (eBR) reviews.

• Review and approve Standard Operating Procedure (SOP) revisions.

• Approve work orders and job plans within the Maximo System.

• Provide quality support and approval for minor deviations and CAPA (Corrective and Preventive Action) records.

• Review and approve Manufacturing Execution System (MES) revisions.

• Evaluate compliance issues, provide recommendations, and ensure timely closure of quality records.

• Represent Drug Product QA during project execution activities.

• Collaborate effectively in a team matrix environment.

Education Qualification:

• Bachelor’s Degree in Biochemistry, Biology, Chemistry, or a related scientific field.

Pay Range:

• $30 - $37 an hr.

Required Skills & Competencies:

• Knowledge and hands-on experience with GMP operations and aseptic manufacturing principles.

• Proficiency in following detailed SOPs, maintaining training records, and adhering to good documentation practices.

• Strong organizational and project management skills, with the ability to meet deadlines.

• Familiarity with Quality Systems and compliance documentation.

• Excellent communication skills, both written and verbal.

• Demonstrated ability to work independently and collaboratively in cross-functional teams.

• Leadership qualities with a drive for continuous improvement and quality initiatives.

Shift : M- F 6am-3pm (Morning), 2pm – 11pm (Swing), 10pm-7am (Night)