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 Role Specific Requirements
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.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
Competencies Required for the Role
EFFECTIVE COMMUNICATION – Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen and show respect for oneself and others in interactions with others. Express oneself clearly in verbal and business writing.
EXECUTION/ACCOUNTABILITY – A willingness to accept responsibility or to account for one’s actions. Accountability is when an individual or a department experiences consequences for their performance or actions.
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. The ability to change or be changed in order to fit or work better on some situation or purpose and embraces change. Strives for continuous improvement.
ANALYTICAL THINKING/PROBLEM SOLVING - Is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this.
THOROUGHNESS/DETAIL ORIENTED – Ensuring that one’s own and others’ work ad information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.
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
Bimeda is an equal opportunity employer committed to fostering a diverse workforce. All qualified applicants will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
