Product Transfer Quality Assurance Lead
Zoetis

Job Info

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Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals.

At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska's Safest Companies, with a long-standing presence in Lincoln and we continue to grow.

Benefits Include:

Great Health Benefits from day 1!

4 weeks accrued paid vacation and 13 paid holidays.

401(k) match with company profit sharing

Tuition reimbursement

Student Loan Repayment Program

Position Summary

Provide quality assurance and compliance expertise for VMRD Pilot and Master Seed facilities, and the design, execution, and transfer of new biological products to ensure department and site objectives are achieved.

Position Responsibilities

• Ensure VMRD Master Seed and Pilot Plant production facilities and the transfer of newly developed and/or improved biological products and processes comply with applicable USDA, EU, FDA, and Zoetis quality standards, as well as the regulatory requirements of destination countries.
• Work in conjunction with VMRD-BDev colleagues on scale-up, technical transfers and coordination of regulatory issues. Serve as QA consultant for the VMRD Pilot Plant and Master Seed Facility. Support VMRD colleagues and initiatives by providing regulatory documents and manufacturing quality/compliance resources.
• Review new product master batch records, all manufacturing and analytical documents for accuracy, completeness, and compliance with Outlines of Production, and provide QA approval. Review and approve validation protocols and reports. Work closely with VMRD, VMRA and GMS in the preparation and review of Outlines of Production.
• Ensure the processes, systems, and facilities of outside suppliers of raw materials and components procured by Lincoln Operations are maintained to provide quality products. Such assurance will be achieved by coordinating and participating in audits and pre-approval surveys of key and potential suppliers, as necessary.
• Ensure continued regulatory compliance within Lincoln Operations by actively participating on teams and making appropriate recommendations when needed to assure compliance.
• Advise Management of regulatory deficiencies and recommend appropriate regulatory actions when products do not meet Zoetis or government requirements.
• Maintain a high level of contemporary knowledge in the technical and regulatory disciplines appropriate to vaccine development.

Education and Experience

Minimum Qualifications:

• BS degree with 10 years' experience, MS. with 8 years' experience, or equivalent, in biological or pharmaceutical sciences, engineering, or related discipline.

• Minimum of five years progressive experience in the quality assurance, manufacturing, quality control, or regulatory affairs function of veterinary or human pharmaceuticals or biologicals.

Preferred Qualifications:

• MS or PhD in a biological science or chemical/ bio process engineering

Technical Skills and Competencies Required

Minimum Qualifications:

• Demonstrated interpersonal and analytical skills with a minimum of 5 years supervisory/leadership experience.

• Experience in Quality assurance auditing, cGMPs, and quality systems

• Demonstrated ability to perform and reach targeted conclusions.

• A thorough knowledge of U.S. and EU regulations for biological products, and their application.

• Must have strong technical/analytical skills and possess a high degree of personal motivation.

• Knowledge of Right First Time and lean principles.

• Strong written and verbal communication skills

• Demonstrated ability to work with internal and external colleagues.

Preferred Qualifications:

• Expert level competency in validation of processes, equipment, cleaning, software, computer systems, etc.

• Solid knowledge of Zoetis Biological products.

Full time

Regular

Colleague

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

This job has expired.