Compliance Specialist, Product Release – Finished Goods

Zoetis is the worlds 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 Nebraskas Safest Companies with a long-standing presence in the Lincoln community. We are a clean modern site that continues to innovate and grow.

Benefits Include:

4 weeks accrued paid vacation and 13 paid holidays.

401(k) match with company profit sharing.

Tuition reimbursement and Student Loan repayment program.

Great Health personal and family benefits starting day 1.

Position Summary

The Compliance Specialist position provides Quality Assurance support for Lincoln manufacturing operations supporting the review and release of biological semi-finished goods and biological and pharmaceutical packaged finished goods. Support product release from the USDA perspective international markets and FDA perspective.

Hours: 1st Shift. Periodic weekend work and off-shift work may be required.

Position Responsibilities

This position is responsible for the creation of release documentation and submission to the USDA for semi-finished biological vaccines and release of packaged biological and/or pharmaceutical finished goods.

• Compile testing results and complete documentation for submission of biological semi-finished goods to the USDA.
• Generate APHIS Form 2008 for submission to USDA.
• Work with the site planning team to evaluate SFG date extension requests.
• Communicate with the ZLIMS team providing regulatory information related to inspection plan characteristics.
• Compile testing results and generate CoA documentation for pharmaceutical products.
• Work with the site supply/planning team to determine product release priorities.
• Ensure compliance with all applicable regulatory requirements and product registrations.
• Understand domestic and international packaging requirements for quality assurance review.
• Check Regulatory Change Request/Submission Action Records (RCR)/(SAR) status and USDA labeling requirements prior to finished goods release.
• Perform product release function for biological and pharmaceutical finished goods.
• Review and approve change controls associated with packaging updates testing plans and new product submissions.
• Perform queries and QA release functions in SAP and Trackwise Event Tracking System (ETS).
• May perform Temperature Excursion Assessments in Libero Manager
• Assist with the RID process and generate product destruct 2008 reports for submission to USDA.
• Advise management of regulatory deficiencies and recommend appropriate regulatory actions when materials do not meet GMS or government requirements.
• Update and manage specification documents.
• Participate on key teams and task forces to address quality issues and improvement projects.
• Other duties as assigned.

Education and Experience

• Bachelors degree with preferred area of study in biology biochemistry chemistry or other science degree.
• Minimum 2 years relevant experience:
  • Job level based on years of relevant experience and working regulatory knowledge:
    • For the GJL 040-2 level
      • Minimum 2 years of progressive experience at the OTE Lead level or above in Manufacturing or Quality Operations
    • For the GJL 060-1 level
      • Greater than 4 years of experience at an Associate Staff level position in Manufacturing or Quality Operations.
    • For the GJL 060-2 level
      • Greater than 3 years of experience at a Staff level position (060-1) in Manufacturing or Quality Operations.

Technical Skills and Competencies Required

• Demonstrated knowledge of APHIS/USDA/FDA/EU regulatory requirements associated with the testing and manufacturing of veterinary biological and pharmaceutical products.
• Significant experience with and knowledge of GMP regulations for commercial manufacturing
• Experience working in core quality systems of ETS SAP LIMS and Veeva Vault
• Ability to make independent decisions based off industry and regulations knowledge.
• Demonstrated ability to write and review technical documents with high attention to detail.
• High integrity and self-motivation
• Effective communication skills written and verbal and the ability to partner and collaborate with partners from various functions.
• Highly organized and detail oriented
• Able to prioritize and multi-task in a dynamic fast paced environment.

Physical Position Requirements

This position will support Lincoln site biological and pharmaceutical product manufacturing release. The position is primarily office based with a significant amount of time spent sitting/working at a computer and processing paperwork. Periodic weekend work and off-shift work may be required.

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 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 site or (2) via email to/from addresses using only the Zoetis domain of @. 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 addition Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.