Proclinical is currently recruiting for a Quality Control Chemist for a pharmaceutical company located in Philadelphia, PA. Successful candidate will perform physical and chemical testing on raw materials, packaging component, in-process, finished products, stability samples, cleaning verification, cleaning validation, process validation following Analytical Methods, Protocols, Procedures (SOPs) and company policies.
- Perform analytical testing of raw materials, in-process, finished product and/or stability samples, cleaning verification, cleaning validation, and process validation following Analytical Methods, Protocols, Procedures (SOPs) and company policies.
- Testing includes, assay, related substance, dissolution, residual solvents, viscosity, pH, Water content, Specific Gravity and other tests according to the analytical methods, USP, procedures in a regulated laboratory environment.
- Analyze samples using appropriate instrumentation such as HPLC, UPLC, GC, Dissolution apparatus, UV, IR, pH, Viscometer etc.
- Perform instrument calibration such as HPLC, UPLC, GC, Dissolution apparatus, UV, IR, pH, Viscometer etc.
- Reviews generated data in a timely manner and elevates any Non-Conformance, Out of Specification, or other Deviation to Laboratory Management promptly for further investigation.
- Follow all SOPs, Safety Guidelines and good housekeeping practices to ensure compliance with cGMP and Housekeeping requirements.
- Identify and troubleshoot problems with instrumentation and analytical preparations.
Skills and Requirements:
- Minimum B.S. Degree in Science Field Chemistry Degree Preferred.
- 1 or more years of experience in an analytical laboratory in pharmaceutical or related field of analytical chemistry.
- Experience in testing raw materials, in-process, finished products and/or stability samples such as assay, related substance, dissolution, residual solvents, viscosity, pH, Water content, Specific Gravity and related testing in an FDA regulated laboratory environment required.
- Basic understanding of cGMPs and compendia procedures where applicable (i.e., USP, NF, BP, etc.) required.
- Demonstrated technical expertise in laboratory instruments, i.e. HPLC, UPLC, GC, UV, Karl Fisher.
- Experience in instrument calibration i.e. HPLC, UPLC, GC, Dissolution apparatus, UV, IR preferred.
- Experience with Empower or related lab software preferred.
- Prior experience in a pharmaceutical (cGMP) laboratories setting is required.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Brandy Plumb at (+1) 646-367-2745 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.