Quality Assurance Associate - QC
As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
The Quality Assurance Associate – Quality Control (QC) is responsible to oversee the Quality Assurance(QA) responsibilities for the Quality Control laboratories, to provide daily assistance and guidance to issues such as non-conformance investigations, change controls, quality training, review and approval of documents and to ensure the adherence to Elanco Quality standards and Regulatory agencies. The QA Associate works as a team member within the quality control teams to achieve site goals while maintaining a strong quality mindset.
- Provide routine and non-routine quality oversight and guidance for the quality control clinical and laboratory teams area
- Provide a daily presence in the quality control environment to enable contemporaneous testing record review, provide quality expertise to laboratory personnel, and conduct trainings to QC personnel on quality topics
- Responsible for review and approval of QC documents, including but not limited to QCPs, SOPs, forms, protocols and reports
- Assist with review of laboratory materials, semi-finished (antigen), and finished materials (vaccine) testing records and summaries.
- Support during internal/external regulatory inspections
- Assess non-conformances that occur within QC and assist with assay disposition, retests, and investigation
- Function as a quality partner, providing guidance to persons writing change controls, impacting QC; responsible to ensure investigations and change controls meet standards
- Perform testing process confirmation against QC procedures and practices
- Mentor and coach site personnel on Quality matters
- Maintain a general working knowledge of manufacturing process, quality systems and QC testing procedures.
- Participate and support regulatory and technical teams in new product and assay development, product and assay transfers, technical improvements, product registrations and regulatory reviews
- Other duties as assigned
- B.S. Degree or equivalent Microbiology/Biology/Chemistry/Engineering (Science or Engineering related degree preferred).
- Minimum of 2 years in a Quality Control or Quality Assurance related role.
- Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing if applicable.
- Must not have contact with avian species (birds) at home due to the nature of the manufacturing
- Root cause analysis, troubleshooting and technical writing skills
- Strong interpersonal and team building skills; ability to lead through influence in a team environment
- Familiarity with USDA regulations and 2008 submission process and standards.
- Proficiency with applicable computer systems, such as SAP, Veeva and Microsoft Office
- Knowledge of or experience in Lean, Six-Sigma or Operational Excellence
- ASQ certification a plus.
- Experience working in an FDA or USDA regulated industry
- Excellent communication, organization, and leadership skills
- Off hours and weekend work may be required
- Potential exposure to chemicals, allergens and loud noises
- Personal Protective Equipment (PPE) and clean room environment may apply.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
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