QC Analyst

Job Description

Our client is  looking to hire a QC Specialist to join our QC-Separations Laboratory, which focuses on supporting the release testing of drug products and drug substances. The successful candidate will assist with laboratory operations, perform sample testing, and fulfill laboratory duties in compliance with cGMP regulations.

Key Responsibilities:

• Conduct release testing for biological products.
• Help update and issue documentation, including SOPs, as needed.
• Perform routine data analysis, assist in investigating OOS results, conduct trending analysis, and write investigation reports.
• Maintain accurate documentation of laboratory work.
• Support technical transfer and co-validation activities.
• Assist with the qualification of laboratory instruments.
• Review data based on proficiency with assays.

Qualifications and Experience:

• Previous experience in a regulated biopharmaceutical laboratory is preferred; experience with HPLC/UPLC and Empower is a plus but not required.
• A minimum of a BSc in Biochemistry or a related field is essential.
• Candidates must demonstrate the ability to work independently and identify unusual trends or results.
• Strong problem-solving skills and the ability to prioritize multiple projects while meeting deadlines are necessary. Excellent communication skills and the ability to work collaboratively in a team environment are required.