QC Analyst II - 3rd Shift

Role Summary:

Reporting to the Quality Control Manager the QC Analyst II is responsible for the analysis of raw materials, in-process, finished products and stability samples using various wet chemistry and instrumentation techniques to assure compliance to cGMP, SOPs and Bimeda quality standards. This position also provides testing support for the Stability Program. Quality Control Analyst II is experienced with all types of laboratory equipment and can troubleshoot common instrumentation issues and provide guidance to junior QC Analysts and Technicians.

Key Responsibilities:

• Conducts all analytical (physical & chemical) testing of raw materials, in-process samples, finished products, gases, water, and stability program samples. i.e., pH, conductivity, TOC, viscosity, potency tests
• Reviews data, results, and documentation for QC analytical testing.
• Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP), and Standard Operating Procedures (SOPs).
• Prepares samples for analysis according to company methods, SOPs, & applicable compendia (USP/EP).
• Performs specific analytical tests utilizing HPLC, GC, UV, IR, FTIR, KF, and other instruments.
• Documents analytical test results as they occur in logbooks and in-process test data in production dockets as required.
• Analyzes data; keeping the supervisor informed of discrepancies, deviations, out-of-specifications (OOS) data and unusual trends as they occur.
• Assists with quality investigations as required.
• Ensures that reagents and supplies are replenished by informing QC Manager or QC Coordinator or preparing PO requisitions when required.
• Performs calibration of equipment, troubleshooting issues, and ensuring equipment is in good working order including arranging repairs when needed with outside vendors.
• Supports and provides training and guidance to junior Analysts and Technicians.
• Ensures that work areas are kept clean and tidy and cleans glassware after use when required.

Other Requirements

• 2-4 years in a Pharmaceutical Analytical testing lab & supporting stability programs
• B.Sc. in Chemistry, Biochemistry, or related discipline
• Analytical Wet Chemistry Lab experience using the following methods/equipment: titration, pH, Potency, Conductivity, Viscosity, TOC, UV, IR, GC, HPLC assays
• High integrity, excellent attention to detail, analytical thinker, ability to organize and prioritize, work in team environment and individually, and take initiative
• Strong problem identification and problem resolution skills
• High level of proficiency with Microsoft Office
• Excellent written and verbal communication skills for liaising and communicating with internal departments and external vendors.
• Strong work ethic and positive team attitude

What We Offer

• Health Insurance (medical, dental, vision)
• 401(k) plan for retirement savings
• Paid time off (vacation, sick leave, holidays)
• Life insurance
• Employee assistance program

About Bimeda

Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals.

Bimeda’s global innovation program sees six state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.

Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.

Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.

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More Info at www.bimedacareers.com