QC Analyst III
About the role:
Reporting to the QC Manager, the role will be responsible for the execution of method transfer tests for new product development, new API sources, technical transfers, and other related activities. The QC Analyst III is the subject matter expert responsible for the more complex analysis using various wet chemistry and instrumentation techniques to assure compliance to cGMP, SOP’s and Bimeda quality standards who will also provide training and technical support to other Analysts as needed.
What you'll do:
Role Specific Requirements
- Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).
- Author, review and execute to method transfer protocols for new product introduction and compendial validation.
- Ability to work directly from the USP or EP pharmacopeia to write protocols and execute methods.
- Expertise with analytical tests utilizing HPLC/UPLC, GC, UV, IR, FTIR, KF and other laboratory instruments.
- Assess, compare, and perform risk assessments for compendial method compliance according to USP, EP, and other regulations.
- Assess analytical methods and perform gap analysis on analytical method validations for NPI. Develop plan and timelines for method transfers, required improvements and justification with approval from team to ensure compliance.
- Conducts complex analytical (physical & chemical) testing of raw materials, in-process samples, finished products required for method transfer and validation.
- Reviews laboratory documentation in notebooks, attachments, chromatography software and specification sheets for accuracy, completeness and compliance with established SOPs, specifications, and methods.
- Conducts the investigation of deviations, out of specification (OOS), and non-conformances. Writes reports as required.
- 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.
- Participates in general lab duties, including clean up, administration, logbook review and operations support.
- Other duties as assigned.
What you bring to the role:
- 5-7 years in a Pharmaceutical Analytical testing lab & supporting stability programs
- Bachelor of Science 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
Competencies required for the role:
- EFFECTIVE COMMUNICATION - 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 in some situations or purpose and embraces change. Strives for continuous improvement.
- ANALYTICAL THINKING/PROBLEM SOLVING - 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.
- DECISIVENESS – The ability to make difficult decisions in a timely manner and avoid procrastinating or asking for unnecessary data or information.
What We Offer:
- Competitive Salary
- Paid Holidays
- Competitive Vacation Policy
- Paid Sick Days
- Medical, Dental, Vision Benefits
- Defined Contribution Pension plan with employer matching
- Employee Assistance Program
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.
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.
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.
More Info at www.bimedacareers.com