Plant QA Senior Associate

We are seeking a highly motivated and experienced Senior Quality Assurance Associate to join a dynamic team within a leading organization in the biotechnology industry. This is a 12-month contract position with the potential for renewal based on performance. The role involves working in a 24/7 shift pattern, providing critical quality support to manufacturing operations.

Responsibilities:

• Serve as a key Quality point of contact for manufacturing operations.
• Provide Quality support for triage and investigation of non-conformance events.
• Review and approve deviations, ensuring compliance with documentation.
• Participate in customer complaint investigations.
• Provide training and advice to staff.
• Observe and support production unit operations, including aseptic interventions.
• Review and approve production batch records and cGMP records.
• Support continuous improvement initiatives.
• Write, review, and approve Standard Operating Procedures (SOPs).

Qualifications:

• University degree in Engineering or Science related discipline.
• 4+ years of relevant experience in the pharmaceutical or biotechnology industry.
• Experience working in aseptic operations, protein formulation, vial, and syringe filling.
• Strong knowledge of regulatory requirements and compliance issues.
• Excellent written and verbal communication skills.
• Proven ability in problem-solving and managing Root Cause Analysis/Deviation investigations.
• Ability to work in a 24/7 shift pattern (7:00-19:00 and 19:00-7:00, four days on/four days off).

Additional Details:

• Shift Pattern: 24/7 shift pattern with a 35% shift rate.
• Important: Candidates must pass an eyesight test before an offer can be made.
• Top Skills: Aseptic experience, experience in manufacturing syringes or liquid products, ability to follow procedures and adapt to changing priorities.

Apply Now:

If you meet the qualifications and are excited about this opportunity, we encourage you to apply.