Job Description

Job Description: QA Associate – On-the-Floor (OTF)

Position Overview: Reporting to the QA Ops Manager, the QA Associate OTF 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:

· Provide support for investigations into deviations from established procedures, specifications, and quality standards.

3. CAPA Implementation Support:

· Collaborate with cross-functional teams to help implementation of CAPAs, ensuring timely and effective resolution of identified issues as it relates to manufacturing activities.

4. Training and Communication:

· Provide training on quality processes and procedures to relevant personnel.

· Communicate quality-related information to manufacturing teams, fostering awareness and adherence to quality standards.

· Provide real-time guidance and support to manufacturing personnel to ensure compliance is upheld and batch records and operating procedure are always followed.

5. Batch Record Issuance and Review

· Provide support for batch record issuance, reconciliation, and perform quality batch record review.

· Work with manufacturing to correct any issues found during the quality batch review and ensure all corrections are made in a timely manner.

6. Other duties as assigned.

Qualifications:

Bachelor's degree in a relevant scientific field with 0-5 years of experience in quality assurance in the biotechnology or pharmaceutical industry.

or

An associate’s degree and a minimum of 2 years of experience in quality assurance in the biotechnology or pharmaceutical industry.

or

A minimum of 3-4 years of experience in quality assurance in the biotechnology or pharmaceutical industry.

· Experience in QA OTF, batch record review, and deviation investigation support preferred.

· Excellent communication and organizational skills.

· Mid-Shift Flexibility is required. Primary shift: 2pm – 10pm.

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