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.
Great Health Benefits from day 1!
4 weeks accrued paid vacation and 13 paid holidays
401(k) match with company profit sharing
The QA Compliance Specialist provides Quality Assurance support for Lincoln Manufacturing Operations, supporting the review and release of biological semi-finished goods and packaged finished goods. Support product release from the USDA perspective, international markets, and FDA perspective.
Education and Experience
- Compile testing results and complete documentation for submission of biological semi-finished goods to the 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.
- Generate APHIS Form 2008 for submission to USDA
- Perform routine batch record review and product release function for biological finished goods.
- 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.
- 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).
- Assist with the RID process and generate product destruct 2008 reports for submission to USDA
- Participate on key teams and task forces to address quality issues and improvement projects
- Advise management of regulatory deficiencies and recommend appropriate regulatory actions when materials do not meet GMS or government requirements
Technical Skills and Competencies
- Bachelor's degree preferred 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' experience at an Associate Staff level position in Manufacturing or Quality Operations.
- For the GJL 060-2 level
- Greater than 3 years' experience at a Staff level position (060-1) in Manufacturing or Quality Operations.
Physical Position Requirements
- Thorough knowledge of APHIS/USDA/FDA/EU regulatory requirements associated with the testing and manufacturing of veterinary biological and pharmaceutical products
- Experience working within a GMP regulated Biotech or Pharmaceutical industry
- Significant knowledge of GMP regulations for commercial manufacturing
- 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
- Experience with MS Word, Excel, Outlook, Trackwise, LIMS, Veeva Vault and SAP
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.
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 firstname.lastname@example.org 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.