Qc Analyst 2

2 weeks ago

Cambridge, Canada Bimeda Full time

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 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.

**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. The 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.

**Responsibilities include but are not limited to**:

- 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.
- Point of contact for troubleshooting analytical equipment and issues.
- Performs calibration of equipment and ensures instruments are in good working order including arranging repairs when needed with outside vendors.
- Provides support, training and expertise across the team.
- 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 Supervisor or preparing PO requisitions when required.
- Ensures that work areas are kept clean and tidy and cleans glassware after use when required.
- Other duties as assigned.

**Requirements**:
**Essential**:

- 3-5 years in a Pharmaceutical Analytical testing lab & supporting stability programs
- B.Sc. in Chemistry, Biochemistry or related discipline.
- Strong analytical skills with both wet chemistry and instrumentation.
- Experience using the following methods/equipment: titration, pH, Potency, Conductivity, Viscosity, TOC, UV, IR, GC, HPLC assays.
- Excellent report writing skills.

**Desirable**:

- Instrumentation troubleshooting skills & background - HPLC, GC, Auto-titrator, UV, FTIR.
- Experience with pharmaceutical analytical testing - raw material, finished product, stability.
- Proven leadership skills.
- Experienced with training new employees - analytical test procedures and instrumentation.
- Analytical protocol & report writing skill - method verification/validation/transfer and non-conformance investigations.

**Core Behaviours, Skills & Abilities**:
**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.

**INTEGRITY/PERSONAL CREDIBILITY **- Demonstrated ability and concern that one be perceived as responsible, reliable and trustworthy.

**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.

**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. St

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