QC Supervisor

POSITION DESCRIPTION

Position Title: Quality Control Supervisor Department: Quality Control

Reports To: Associate Director of Quality Control Work Location: Decatur, Illinois

Position Summary:

Perform testing on raw materials, bulk formulations, finished products, stability samples, and any other samples from plant operations that require chemical analysis.

Essential Duties & Responsibilities:

Experience in method validation, method transfers activity of injectable, ophthalmic drug product, drug substance, raw material, etc.

Review of the method validation/method transfer activity per ICH/USP requirements.

Responsible for writing method validation/verification protocol/reports.

Responsible for writing qualification/validation protocols and reports.

Allocation daily work to lab chemist based on priority.

Maintain and monitor lab instrument qualification/ calibration schedule.

Responsible for writing test method, specification, etc.

Review of analytical data of all analytical instruments and logbooks.

Review of qualification/ calibration records.

Experience in the operation of handling QC major instruments like HPLC, GC, UV, IR, Auto titrator, etc.

Perform Finished product/in-process/cleaning validation and raw material analysis independently.

Complete testing within specified timeframes and document results accurately.

Experience in integration of chromatograms through chromeleon chromatographic software. Review of analytical method/specification and prepare GAP analysis. Coordinate with R&D lab for method validation, method transfer related query, and questions.

Responsible for writing an investigation report for OOS/OOT.

Preparation of stability schedule, Protocol, and report per requirements.

Adhere to regulatory guidelines (e.g., FDA, ICH, GMP) and company quality standards during testing and documentation. Ensure adherence to Good Laboratory Practices (GLP), Good Documentation Practices (GDP).

(GDP) and Good Manufacturing Practices (GMP) during testing procedure.

Education and Experience:

Bachelor's Degree from a four-year accredited college or university with Major in Chemistry or equivalent. Two years of industry experience involving analytical or wet chemistry test procedures in a quality control environment.

Job Prerequisites:

Bachelor's Degree from a four-year accredited college or university with Major in Chemistry or equivalent.

Two years of industry experience involving analytical or wet chemistry test procedures in a quality control environment.

Experience with Infra-Red (IR), Ultraviolet/Visible Spectroscopy, Particle Size Analysis, KF Titration, and wet chemistry skills are required. Familiarity with High Pressure Liquid Chromatography, Gas Chromatography (GC), and HPLC/GC analytical software is preferred.

Familiarity with GLP/GMP guidelines.

Good Communication and writing skills. Familiarity with out-of-specification (OOS) investigation. Computer literate.

Experience with USP/EP monographs

Physical Demands, Mental requirements, and Work Environment:

While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use. Requires eye-hand coordination and manual dexterity. Requires normal range of hearing and vision to record, prepare and communicate appropriate reports. Will come in contact with hazardous materials. Employee is expected to work with hazardous materials in a safe manner and use all safety precautions.

Mental Requirements

Effective written and oral communication skills. Strong organizational, planning, and communication skills. Using logic and reasoning to identify solutions to problems. Ability to multi-task, set priorities, and meet strict deadlines; and Ability to lead, motivate, coach, and teach others. Ability to accurately communicate ideas, facts, and technical information. Ability to meet deadlines and effectively deal with office stress. Ability to follow safety and security practices. Ability to receive instructions and follow work rules and company policies.