Senior Peer Reviewer

Peer Reviewer III is responsible for reviewing and approving laboratory-generated data to ensure accuracy and compliance with procedures and cGMP requirements. Complete audit tasks within the specified time frame without compromising audit quality. Continuously improve the documentation system to increase efficiency and GLP compliance. Report all audit findings in audit reports and highlights, and report any critical deficiencies.

Essential Functions:
- Review laboratory testing records against written procedures/specifications, SOPS, and company policies.
- Review laboratory instrument calibration/qualification records, standard qualification records, and records associated with investigations.
- Review raw materials, excipients, and finished product data for data integrity and compliance with specifications, methods, and USP monographs as applicable.
- Review analytical method validation/verification data for compliance with protocols and ICH guidelines.
- Review stability data to identify trends, alert limits, and OOS.
- Participate in audits of laboratory activities to determine improvement needs for maintaining cGMP compliance.
- Prepare for pre-approval audits for filed ANDAs.

Additional Responsibilities:
- Perform other duties as assigned.

Qualifications:
- Education: Bachelor’s Degree (BA/BS) — Required.
- Experience: 6+ years as a scientist or group leader in a pharmaceutical laboratory.