Quality Control Supervisor - Chemistry

Quality Control Chemistry Supervisor

Overview:

Quality Control (QC) Chemistry Supervisor oversees the daily testing of raw materials, in-process samples, finished products and stability. In addition, they oversee the daily operations of the analytical chemistry laboratory. They lead teams of QC analysts, ensure adherence to cGMP guidelines, and manage laboratory compliance, investigations, and instrumentation to guarantee product safety and regulatory approval.

Key Duties:

These are only highlighted by major key duties. Other requested duties assigned by Eagle Labs, Inc for job function by Quality Control Manager, Director of Laboratory Operations, or Executive leadership.

• Supervise, train, and mentor QC analysts. Manage scheduling, performance evaluations, and daily workload distribution to meet production timelines


• Managing 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 that 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.

Core Responsibilities:

• Team Leadership & Operations: Manage daily lab workflows, scheduling, and workload distribution. Oversee training, performance evaluations, and mentorship for QC chemistry analysts.


• Analytical Testing & Data Review: 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.


• Quality & Compliance Management: 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.


• Audits: Participate in internal and regulatory facility audits (e.g., FDA inspections) and ensure the laboratory remains audit-ready at all time


• Lab Infrastructure & Auditing: Maintain an audit-ready laboratory environment. Ensure analytical instruments are calibrated, maintained, and validated according to strict regulatory standards.

Qualifications & Requirements:

• Education: A Bachelor's degree or higher in Chemistry, Biochemistry, or a closely related scientific discipline.


• Experience: Minimum –5 years of relevant pharmaceutical QC experience, with at least 3 or more years in a direct supervisory or leadership role.


• Regulatory Knowledge: Deep understanding of cGMP, FDA regulations, and pharmacopeial standards (e.g., USP, EP).


• Soft Skills: Strong problem-solving, data trending capabilities, and excellent verbal and written communication skills.


• Technical Skills: Proficiency in advanced laboratory software (e.g., LIMS, Empower)