Compliance Specialist, Product Release - Finished Goods
Zoetis, Lincoln, Nebraska, United States, 68511
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, 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. About Zoetis
At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award‑winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well‑being in every sense, from health and financial wellness to family and lifestyle resources.
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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, 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. About Zoetis
At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award‑winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well‑being in every sense, from health and financial wellness to family and lifestyle resources.
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