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. 
