QC Analyst III

Role Summary

Reporting to the QC Project Lead, the role is responsible for analysis of raw materials, in-process and finished products, stability samples and packaging components using various instrumentation and wet chemistry techniques. The role works in compliance with cGMP, SOPs and Bimeda quality standards.

Additionally, in support of Bimeda’s new product launches, the QC Analyst III is responsible for method transfers for new product developments, new API sources, technical transfers and other related activities.

The QC Analyst III is a subject matter expert in pharmaceutical chemistry testing and responsible for the department’s more complex analyses using various wet chemistry and chromatography instrumentation techniques while assuring compliance to cGMP, SOP’s, and Bimeda quality standards.

The QC Analyst III also provides support to QC Analysts through training, technical support & expertise, and supports department GMP compliance issues as needed.

Shift Availability: Friday-Saturday-Sunday-Monday: 10Hrs.

Key Role Specific Requirements

1. Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).
2. Responsible for lab operations, safety, and schedules for their team.
3. Expertise with analytical tests utilizing HPLC/UPLC, GC, UV, IR, FTIR, KF and other laboratory instruments.
4. Supports QC Analysts through training, technical support & expertise, and supports department GMP compliance items as needed.
5. Conducts analytical (physical & chemical) testing of raw materials, in-process & finished products, stability samples and packaging components.
6. Leads by example and proactively communicates and collaborates with internal staff and colleagues to achieve objectives.
7. Contributes and leads departmental CR/OOS/CAPA/Deviations.
8. Collaborates with the QC management team and other internal departments on a regular basis to gain oversight on the weekly manufacturing production / final release product planning and assists in the creation of the test schedule for the QC team.
9. Initiates deviations and investigations for any applicable nonconformances. Works with other departments and leads QC investigations to ensure accuracy and completeness of out-of-specifications, out-of-trends, deviations, incident reports and non-conformances.
10. Ability to work directly from the USP or EP pharmacopeia to write protocols and execute methods, and is able to assess, compare and perform risk assessments for compendial method compliance according to USP, EP, and other regulations.
11. Reviews laboratory documentation in notebooks, attachments, chromatography software and specification sheets for accuracy, completeness and compliance with established SOPs, specifications and methods.
12. Conducts the investigation of deviations, out of specification (OOS), and non-conformances. Writes reports as required.
13. Verifies and processes analytical data for method transfer. Writes technical documents such as methods, specifications, SOPs, method validation protocols and reports, method transfer protocols and reports.
14. Other duties as assigned.

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

1. INTEGRITY/PERSONAL CREDIBILITY – Demonstrated ability and concern that one be perceived as responsible, reliable and trustworthy.
2. FOSTERING COLLABORATION/TEAMWORK – The 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; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.
3. INITIATIVE – Identifying what needs to be done and doing it before being asked or before the situation requires it.
4. THOROUGHNESS/DETAIL ORIENTED – Ensuring that one’s own and others’ work and information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.
5. PLANNING – The process of thinking about and organizing the activities required to achieve a desired goal.

Other Requirements

Essential:

1. 5-7 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.

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