QA Investigation Reviewer Lead
Provides QA leadership and oversight for GTx investigations. Performs investigation review and participates on teams investigating manufacturing or laboratory deviations. Supports determination of product impact, identification of root cause and appropriate CAPA. Ensures investigation results and conclusions are documented, consistent and supported by data. Provides training and mentoring for other colleagues. Provides leadership for metric review and program improvements. Perform all duties in compliance with site and corporate cGMP, safety, environmental and human resource policies and procedures.
Review and approve investigations by performing the following:
- Review supporting documentation including batch documentation, testing results, training records, calibration records, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents in support of the investigation
- Interact and coordinate with appropriate personnel including manufacturing, clinical, QA/QC, regulatory, technical services, etc.
- Communicate immediately with Quality management for all GMP deviations that impact product.
- Support lead investigator to identify root causes of the GMP deviation by participating in Method 1s
- Support identification of proposed CAPAs
- Assess the impact of deviations on products or processes and recommend product disposition.
- Ensure clear and concise summaries of investigations, product impact assessments, and commitments
- Ensure that all procedurally defined timelines are followed.
Ensures timely completion of investigation commitments. This includes verification that all drafting and revision of change controls, standard operating procedures, testing specifications, batch documentation, training documentation, validation/technical documentation, work orders, purchase orders, and others meet the intent of the CAPAs.
Maintains regulatory compliance by initiating investigations as needed and ensuring that all colleagues document all deviations and resulting changes, whether process, equipment, or procedural, per regulatory and company policies.
- Minimum 8 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field
- Minimum 5 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field
- 0-1 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a PhD in Science/related field
- Some expertise in performing or reviewing Investigations (ER/QAR, LIRs, Complaints and/or EHS) required.
Experience with relevant QTS modules and QRM practitioner preferred.
Ability to stand for 1 hour at a time, sit for 2 to 3 hours at a time. Require working in an office setting where sitting and computer usage would be typical.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Limited travel for the position; no more than 10% traveling.
Other Job Details:
- Last Date to Apply for Job: 10/12/21
- Relocation support available
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