Quality Control Chemist II

Quality Control Chemist:

MAJOR RESPONSIBILITIES:

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.

 

 

QUALIFICATIONS

The successful candidate will possess:

1. Master’s Degree in Chemistry or life sciences with 2-5 years of experience in GMP environment;
2. Hands-on experience with HPLC/UPLC, GC, GC-MS/LC-MS, KF, IC;
3. Hands-on experience with Empower and Chemstation. Experience with MassLynx is desirable;
4. Familiarity with both CFR 21 and ICH guidelines in regards to GMP;
5. Computer skills in MS Word, EXCEL, and Access; and
6. Strong interpersonal and communication skills (oral and written).