FSQR USP/ Lab Supervisor
On-siteRittman, Ohio, United States
Job Summary
Oversee FSQR USP laboratory testing, release, and GLP programs while ensuring compliance with USP specifications and regulatory requirements. Conduct root cause analysis for customer complaints and drive corrective action plans up to manufacturing processes. Support the FSQR Manager during audits, lead site validation studies, and coordinate testing schedules with operations. Supervise USP technicians, review COAs and work orders, and generate or revise relevant SOPs. Manage calibration of lab equipment and assist with new hire and annual training. Review USP trends and reporting requirements, ensuring facility GMP and prerequisite program compliance.
Required Qualifications
- Bachelor's degree in Chemistry, Biology, Food Science or other related science field
- Minimum of 2 years experience working in a USP / pharma manufacturing environment or quality laboratory
- Strong knowledge of 21CFR 210, 21CFR 211, ICH Q7 or other applicable pharma regulations
Desired Qualifications
- Supervisory experience
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