Pharmaceutical Quality Control (QC) Lab SupervisorSupervises, plans, organizes, directs and evaluates the activities of the Quality Control Laboratory. Responsible for the daily operation operations and control of the workflow. Implement and enforce testing standards and policies and ensure quality and regulatory compliance. This "working supervisor" role balances hands-on technical testing with administrative management, such as scheduling, training, and investigating laboratory deviations like
Out of Specification (OOS) results.
Core Responsibilities- Laboratory Management: Oversee daily testing of raw materials, in-process samples, and finished products while managing laboratory resources, and instrument calibration and maintenance. Ensure completion of all testing, including special project/protocol testing in a timely and appropriate manner.
- Personnel Leadership: Supervise a team of QC analysts or technicians, including hiring, performance reviews, scheduling shifts, and providing training on test methods. Ensure employees are properly trained and perform tasks according to company policies and procedures. Evaluate performance appraisals and ensure employees have career development plans. Make appropriate staffing recommendations
- Quality, Documentation and Compliance: Assist in implementing quality and regulatory requirements (eg. FDA, GLP, cGMP, USP and Ph. Eur guidelines), and ensure compliance with testing SOPs and specifications. Monitor the testing techniques and accuracy of all records and documentation done in the lab. Review and approve analytical batch records, logbooks, and technical reports to ensure full compliance with FDA and internal Standard Operating Procedures (SOPs).
- Quality Investigations and Audits: Lead investigations into atypical test results (OOS, OOT), perform root-cause analysis, and implement Corrective and Preventive Actions (CAPA). Conduct audits for documentation, cGMP and Safety to maintain compliance.
- Equipment Calibration and Maintenance: Assure equipment maintenance and calibration, and internal audits are performed on schedule.
- Method Development and Validation: Assist in the validation, optimization, and implementation of new chemical and physical test methods to improve lab efficiency.
- Inter-departmental Liaison: Act as the primary point of contact between the lab and departments like Manufacturing, R&D, Synthetic Chemistry and Quality Assurance to resolve quality issues.
- Budgeting: Monitor the expenses, and recommend instrumentation purchases and upgrades for the laboratory that ensures optimum lab performance.
RequirementsEducationBachelor's or Master's degree in Chemistry, Biology, or a closely related scientific field.
Experience5+ years in a pharmaceutical QC or R&D laboratory, often including 1-2 years in a lead or supervisory role. Familiar with commercial products.
Technical SkillsAdvanced knowledge of laboratory instrumentation (HPLC, GC, FTIR, MS), data integrity principles (
ALCOA++), and software applications 9eg. Open Lab CDS, Mass Hunter.
CertificationsThorough understanding of
cGMP and FDA regulations.
Soft SkillsStrong attention to detail, proactive problem-solving, and excellent written communication for technical reporting.
