QC Analyst II (Afternoon Shift)- Full Time

About the Role

Reporting to the Quality Control Supervisor, 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.

Shift Availability: 2nd Shift: Monday - Friday, 3:00PM - 11:30PM

Responsibilities include but are not limited to:

1. 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 and impurity tests.
2. Reviews data, results and documentation for QC analytical testing.
3. Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).
4. Prepares samples for analysis according to company methods, SOPs & applicable compendia (USP/EP).
5. Performs specific analytical tests utilizing HPLC, GC, UV, IR, FTIR, KF and other instruments.
6. Documents analytical test results as they occur in logbooks and in-process test data in Production dockets as required.
7. Analyzes data; keeping the supervisor informed of discrepancies, deviations, out of specifications (OOS) data and unusual trends as they occur.
8. Assists with quality investigations as required.
9. Ensures that reagents and supplies are replenished by informing QC Supervisor or preparing PO requisitions when required.
10. Performs calibration of equipment, troubleshooting issues and ensuring equipment is in good working order including arranging repairs when needed with outside vendors.
11. Supports and provides training and guidance to junior analysts.
12. Ensures that work areas are kept clean and tidy and cleans glassware after use when required.
13. Other duties as assigned.

Requirements

Essential:

1. 3-5 years in a Pharmaceutical Analytical testing lab & supporting stability programs.
2. B.Sc. in Chemistry, Biochemistry or related discipline.
3. Analytical Wet Chemistry Lab experience using the following methods/equipment: titration, pH, Potency, Conductivity, Viscosity, TOC, UV, IR, GC, HPLC assays.

Core Behaviors, Skills & Abilities:

1. THOROUGHNESS / DETAIL ORIENTED – Ensuring that one’s own and others’ work and information are complete and accurate; carefully preparing for meetings and presentations and following up with others to ensure that agreements and commitments have been fulfilled.
2. INTEGRITY / PERSONAL CREDIBILITY – Demonstrated ability and concern that one be perceived as responsible, reliable and trustworthy.
3. ANALYTICAL THINKING / PROBLEM SOLVING – Ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations.
4. CHANGE AGILITY / ADAPTABILITY – The ability to demonstrate support for innovation and for organizational changes needed to improve the organization’s effectiveness; initiating, sponsoring, and implementing organizational change.
5. FOSTERING COLLABORATION / TEAMWORK – Ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team.

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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