Under the direction of the Stability Supervisor, the QC Chemist will support manufacturing activities by accurately performing stability testing. QC Chemists are responsible for analyzing test data and with management support utilizing professional judgement to recognize trends and alert the Stability Supervisor.
Major Duties and Responsibilities:
- Perform analytical testing on finished products for routine stability samples using the following techniques for which training has been appropriately documented: HPLC, GC, UV, UV, IR, viscometer and others as required using established written procedures and specifications.
- Prepare standards, samples, solvent mixtures, test solutions and reagents accurately and precisely for laboratory testing.
- Operate and maintain analytical instrumentation and equipment, including daily verifications, as per established procedures.
- Perform all assigned tasks in a timely and organized manner in accordance to cGMP, OSHA and company policies and procedures.
- Assist in OOS investigations for the adjustment and disposition on non-conforming materials.
- Accurately documents testing information and results in “real time” in the appropriate laboratory notebook or logbook.
- Perform stability testing of drug products according to established written protocols, procedures and specifications.
- Ensure all methods used have been verified or validated as appropriate prior to use.
- Perform peer review of analytical testing in the QC lab as needed.
- Maintain organization and cleanliness of personal and shared laboratory spaces.
Education and Experience
- Bachelor’s Degree or higher in Chemistry or related scientific field.
- 1-3 year’s laboratory experience.
- Experience in Pharmaceutical QC preferred including USP/NF testing, with knowledge of FDA and ICH regulatory guidelines.
- Basic understanding of cGMP.
- Working knowledge of MS Word and MS Excel.
- Good written and communication skills.
- Comfortable in a fast-paced environment with ability to adjust workload based upon changing priorities.
- Self-motivated and detail oriented with good time management, prioritization and personnel interaction skills.