Compliance Specialist, Product Release – Finished Goods

Compliance Specialist, Product Release – Finished Goods page is loaded## Compliance Specialist, Product Release – Finished Goods locations:
Lincoln time type:
Full time posted on:
Posted Yesterday job requisition :
JR
** 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 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
*** Bachelor’s 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,…