Sr QC Chemist

Responsibilities

• Review/test raw materials (RM), packaged materials (PM), in-process (IP), and finished products to ensure quality standards are met.
• Carry out method transfer and verification, including investigation of out-of-specification (OOS) and out-of-trend (OOT) results.
• Ensure laboratory compliance through audits and data integrity practices.
• Manage sampling and testing for raw and packing materials, distributing work among 2-3 team members from sample collection to result generation.
• Prepare specifications for raw materials, packing materials, and finished products according to USP/US Pharmacopeia standards.
• Perform chemical testing using techniques such as FTIR, Karl Fischer titrations, and UV-Vis spectroscopy.
• Assess and approve test limits and testing procedures based on pharmacopeial requirements.

Requirements

• BS/MS in Chemistry, Pharmacy, Pharmaceutical Sciences, Microbiology, or related discipline.
• 5-8 years of QC experience in pharmaceutical sterile injectable manufacturing.
• Experience with USP/US Pharmacopeia, including preparation of specifications and chemical testing.
• Proficiency in FTIR, Karl Fischer Titrations, and UV-Vis techniques.
• Strong knowledge of method transfer, investigations (OOS/OOT), and laboratory compliance.
• Ability to review data, perform audits, and maintain data integrity.

Qualifications

Not specified.

Skills

Not specified.

Benefits

Health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

Pay

Not specified.

Schedule

Onsite – onsite.