Quality Control Supervisor - Chemistry

Oversees the daily testing of raw materials, in-process samples, finished products, and stability. Leads the analytical chemistry laboratory, ensuring adherence to cGMP guidelines, managing compliance, investigations, and instrumentation to guarantee product safety and regulatory approval.

Responsibilities

• Supervise, train, and mentor QC analysts.
• Manage scheduling, performance evaluations, and daily workload distribution to meet production timelines.
• Lead a team of analysts, ensuring compliance with cGMP/GLP, reviewing test data, investigating out-of-specification (OOS) results, and managing stability programs and method validations.
• Enforce strict laboratory safety standards and maintain compliance with chemical hygiene plans.
• Ensure critical analytical instruments (e.g., HPLC, GC, FTIR, UV-Vis) are routinely calibrated, maintained, and verified for compliance.
• Ensure data integrity.
• Act as a subject matter expert (SME) during internal audits and regulatory inspections.
• Manage daily lab workflows, scheduling, and workload distribution.
• Oversee training, performance evaluations, and mentorship for QC chemistry analysts.
• Ensure routine and non-routine chemical assays are performed accurately.
• Review and approve analytical data generated from techniques like HPLC, GC, dissolution, and wet chemistry.
• Spearhead investigations into Out-of-Specification (OOS) and Out-of-Trend (OOT) results.
• Author, revise, and approve Standard Operating Procedures (SOPs), protocols, and technical reports.
• Participate in internal and regulatory facility audits (e.g., FDA inspections) and ensure the laboratory remains audit-ready at all times.
• Maintain an audit-ready laboratory environment.
• Ensure analytical instruments are calibrated, maintained, and validated according to strict regulatory standards.

Requirements

• Bachelor's degree or higher in Chemistry, Biochemistry, or a closely related scientific discipline.
• Minimum of 5 years of relevant pharmaceutical QC experience, with at least 3 or more years in a direct supervisory or leadership role.
• Deep understanding of cGMP, FDA regulations, and pharmacopeial standards (e.g., USP, EP).
• Strong problem-solving, data trending capabilities, and excellent verbal and written communication skills.
• Proficiency in advanced laboratory software (e.g., LIMS, Empower).