Quality Control Chemist:
Key responsibilities of the role to include the following.
- Basic understanding and knowledge of instrumentation, lab functions, and techniques to identify problems and support the completion of work assignments.
- Perform and review QC stability as well as release testing.
- Support routine analytical testing using GC, KF, and HPLC.
- Maintain the QC lab by ordering supplies routinely used for testing.
- Assist the QC/QA group with writing and editing of SOPs and STPs.
- Support analytical method development.
- Perform method transfer and validation activities.
- Perform OQ/PQ for the Quality Control Equipment.
- Train and oversee junior chemists for routine QC activities.
The successful candidate will possess:
- Master’s Degree in Chemistry or life sciences with 2-5 years of experience in GMP environment;
- Hands-on experience with HPLC/UPLC, GC, GC-MS/LC-MS, KF, IC;
- Hands-on experience with Empower and Chemstation. Experience with MassLynx is desirable;
- Familiarity with both CFR 21 and ICH guidelines in regards to GMP;
- Computer skills in MS Word, EXCEL, and Access; and
- Strong interpersonal and communication skills (oral and written).