Job Description

Quality Control Analyst Lead (2nd Shift)

FAST growing Global Pharmaceutical Manufacturing Company has an immediate DIRECT HIRE opening for a Quality Control Analyst Lead to join their team! The company offers a very competitive compensation and benefits package as well as an extremely friendly and collaborative work environment.

Purpose

To provide compliance and testing support to the Quality Control Laboratory and leadership to Quality Control Analysts in a manufacturing site environment.

Qualifications

• Working knowledge of laboratory instrumentation to include GC, GC-MS, ICP-MS, IR, Karl Fischer, pH, UV-VIS, Density, Auto-titration, and Refractive Index.
• Experience in analytical method development, method transfer, method verification, and validation.
• Experience with laboratory instrument qualification, preventative maintenance, and calibration.
• Experience in supporting FDA, EU, corporate & other regulatory audits.
• Technical writing experience including writing SOPs, test methods, and authoring or reviewing protocols in a pharmaceutical manufacturing laboratory environment.
• Experience with deviation investigations, laboratory investigations, change controls, and CAPA.
• Proficiency with computer office tools (Word, Excel, LIMS, Outlook & scientific databases, etc.) is required.
• Ability to work in a fast-paced environment and manage priorities & maintain timelines for multiple projects is essential.
• Knowledge of FDA regulations, ICH guideline, and cGMP guidelines & their applications.
• Needs to be highly motivated and flexible, with excellent problem-solving skills.
• Advanced verbal, technical writing and interpersonal communication skills.

Requirements

• B.S. in Chemistry or scientific discipline is required.
• Minimum 3 plus years’ experience working in a pharmaceutical QC manufacturing laboratory environment with emphasis utilizing Gas Chromatography.
• Strong documentation skills.
• Some knowledge of pharmaceutical regulations & audit experience a plus.

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