Operations Quality Support Specialist

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.

Position Description: The OQST is responsible to oversee quality assurance responsibilities for the NAV department, to ensure the quality and compliance of veterinary biologics with GMP standards and adhere to guidelines set forth by regulatory agencies and Elanco policies.

Salary Range: The salary range for this position will be approximately $52,500 to $70,000 annually, which will be determined based on education and experience.

Functions, Duties, Tasks:

• Support contemporaneous batch record review and ensure on time completion.
• Provide trainings to production personnel.
• Complete routine reviews of production logbooks.
• Support supervisor with updating production batch records, SOP’s, job aids and forms.
• Own CAPAs, Deviations, Change Controls and compose technical assessments (i.e., risk assessments) with NAV supervisor.
• Maintain quality backlog list and ensures completion of tasks in a timely manner.
• Maintain a general working knowledge of manufacturing processes in the process team functional area.
• Provide routine trending of departments quality metrics and identify negative trends to enable action.
• Other duties as required.

Minimum Qualifications (education, experience and/or training, required certifications):

• Post-secondary education in the field of science/biotechnology sciences (preferably a Bachelor of Science degree or Technical Diploma in Biotechnology) is preferred.
• 1-2 years of experience in the GMP bio manufacturing industry (preferred).
• Intermediate computer skills using MS Office (Word, Excel, Power Point) able to learn new computerized system such as SAP, Veeva.
• Experience performing investigations and writing deviations is essential.
• Thorough technical understanding of quality systems and regulatory requirements.
• Excellent interpersonal skills, both communications and written in English.

Other:

• Working Hours: 40 hours per week.
• Must have the flexibility/ability to work evenings and weekends if the business requires it.
• Must have the flexibility/ability to work overtime if the business requires it.

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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