Quality Control Chemist (Senior Level)
Position Summary
The Senior Quality Control Chemist performs complex and routine analytical testing to support raw material qualification, in‑process control, and finished product release within a regulated pharmaceutical environment. This role ensures laboratory compliance with GMP/GLP requirements, leads technical investigations, supports CAPA activities, and contributes to continuous improvement initiatives and the introduction of new analytical technologies.
Key Responsibilities
Analytical Testing & Laboratory Operations
- Prepare standards, reagents, and sample solutions for testing.
- Perform wet chemistry and instrumental analyses, including HPLC, GC, FTIR, UV‑Vis, Dissolution, Instron, and Texture Analysis.
- Execute testing of Incoming Raw Materials and Finished Products in accordance with USP/NF/EP and approved internal methods.
- Meet required testing cycle times through effective scheduling, execution, and documentation review.
- Support equipment qualification, calibration, and routine maintenance.
Documentation & Compliance
- Author, revise, and review SOPs, analytical methods, specifications, and worksheets.
- Ensure all work complies with GMP/GLP requirements and internal quality standards.
- Maintain accurate, complete, and audit‑ready laboratory records.
Investigations & Quality Support
- Lead or contribute to laboratory investigations, including root‑cause analysis and non‑conformance resolution.
- Drive CAPA activities to timely completion.
- Support audits, inspections, and quality system improvements.
Continuous Improvement & Technical Leadership
- Participate in or lead continuous improvement initiatives to enhance laboratory efficiency and data integrity.
- Support the evaluation and implementation of new analytical techniques, instrumentation, and workflows.
- Provide technical guidance to junior chemists and cross‑functional partners as needed.
- Work flexible hours to meet testing or project demands.
Minimum Qualifications
- Bachelor’s degree in a scientific discipline (Chemistry preferred).
- Pharmaceutical analytical testing experience in a GMP/GLP environment.
- Perform wet chemical and instrumental analysis, including FTIR, HPLC, UV, Dissolution, Instron, Texture Analyzer, and GC
- Strong understanding of compendial testing and global regulatory expectations.
- Demonstrated ability to lead technical investigations and support CAPA activities.
- Approximately 10+ years of analytical testing experience.
Preferred Qualifications
- Experience with raw material testing, global compendia (USP/NF/EP), and ICH guidelines.
- Familiarity with inhalation, transdermal, or other specialized dosage forms.
- Strong written and verbal communication skills, including technical documentation.
