Manager, GMP Quality Control

We are seeking qualified individuals to join us as Quality Control Manager. Core duties and responsibilities include the following: Job Duties: - Lead and develop a QC laboratory team of approximately 5-8 analysts and chemists; manage daily priorities, workload, scheduling, training, qualification, performance, and backup coverage. - Maintain a regular hands-on presence in the laboratory to understand process details, coach analysts, answer technical questions, and help troubleshoot testing and instrument issues in real time. - Ensure timely execution and documentation of in-process, raw-material, release, stability, cleaning, investigation, or other assigned testing in accordance with approved methods, specifications, SOPs, and schedules. - Review analytical data, calculations, chromatograms, audit trails, worksheets, and reports for accuracy, completeness, data integrity, and compliance. - Oversee and contribute to analytical method transfer, verification, validation, troubleshooting, and lifecycle improvement for peptide characterization methods, including HPLC and LC-MS-based methods as applicable. - Lead or support laboratory investigations, OOS/OOT assessments, deviations, CAPAs, and change controls; ensure actions are scientifically sound, documented, and completed on time. - Coordinate instrument qualification, calibration, preventive maintenance, service, troubleshooting, and laboratory supply readiness for assigned equipment. - Partner with Quality Assurance on specifications, testing status, investigations, and batch-disposition decisions; provide complete QC data and recommendations while preserving QA's final disposition authority. - Support process characterization, scale-up, technology transfer, new-product introduction, and customer method transfer by providing practical analytical planning and execution. - Prepare or review QC portions of regulatory, customer, and technical data packages; ensure source data and controlled records are complete and traceable. - Serve as the QC subject-matter expert during regulatory, customer, and internal audits and support responses and corrective actions for QC-related observations. - Manage laboratory vendors, service providers, operating supplies, and the approved QC budget. - Track and communicate laboratory metrics including turnaround time, schedule adherence, right-first-time documentation, investigation aging, instrument availability, and training status. - This is not a desk-only scheduling role. The Manager is expected to understand the work at the process and instrument level and remain available on the laboratory floor when the team needs technical direction. - The Manager must be able to demonstrate procedures, train personnel, review work, troubleshoot issues, and make sound decisions about when testing may proceed, pause, or require escalation. - The role requires balancing laboratory presence with planning, documentation review, people management, meetings, and cross-functional coordination. Requirements - Bachelor's degree in chemistry, analytical chemistry, pharmaceutical sciences, biochemistry, or a related discipline. - 6+ years of analytical chemistry or QC experience in pharmaceutical, biopharmaceutical, API, or another GMP-regulated environment. - 5+ years of hands-on experience with HPLC, LC-MS, or other relevant analytical instrumentation and data systems. - 2+ years of direct leadership experience supervising a QC laboratory, analytical team, or comparable technical group. - Working expertise in analytical method validation or verification, release testing, stability testing, and cGMP laboratory documentation. - Strong understanding of data integrity, OOS/OOT investigations, deviations, CAPA, change control, instrument qualification, and controlled methods. - Demonstrated ability to train analysts, troubleshoot technical problems, set priorities, and maintain testing turnaround in a fast-moving environment. - Strong written and verbal communication and the ability to work effectively across Manufacturing, Quality Assurance, Materials, Validation, and Project Management. Benefits - Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee's family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed) - Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental). - Disability insurance 50% standard employer paid. - 401k 10% 1:1 match - PTO policy. 10 days PTO - Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25 - Carpool, clean air vehicle, and cell phone reimbursement - Employee rewards and recognition program - Company organized social events - Quarterly sponsored team building activities