What are the responsibilities and job description for the Quality Assurance Associate - On-the-Floor (OTF position at Wheeler Bio, Inc.?
Job Description
Job Description
Position Overview : Reporting to the QA Manager, the QA Associate OTF (Mid-Shift) role primarily focuses on QA oversight on the floor of all GMP Manufacturing processes by providing real time quality inspections and collaborating with the production team to understand and resolve quality concerns immediately on the floor. The QA Floor Associate is essential for maintaining GMP compliance and supporting all manufacturing processes.
Key Responsibilities :
1. On-the-Floor :
- Ensure regular presence in operational areas to monitor GMP programs and quality systems including various production activities such as seed train activities, bioreactor inoculation, master cell bank production, etc.
- Review batch records to ensure adherence to standard operation procedures and correct any issues in real time.
- Collaborate closely with process teams to resolve quality issues and operational support and necessary escalation.
- Review logbooks and equipment maintenance records to ensure compliance with manufacturing activities.
- Ensuring that any issues needing escalation are done in a timely and efficient manner.
- During active projects / processing, the OTF mid-shift will be primarily covering operations that occur in the afternoon – evening.
2. Deviation Investigation Support :
3. CAPA Implementation Support :
4. Training and Communication :
5. Batch Record Issuance and Review
6. Other duties as assigned.
Qualifications :
Bachelor's degree in a relevant scientific field with 0-2 years of experience in quality assurance in the biotechnology or pharmaceutical industry.
An associate’s degree and a minimum of 2 years of experience in quality assurance in the biotechnology or pharmaceutical industry.
A minimum of 3-4 years of experience in quality assurance in the biotechnology or pharmaceutical industry.
