Compliance Specialist, Product Release - Finished Goods

Role 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.

Responsibilities

• 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.

Qualifications

• Minimum 2 years relevant experience in Manufacturing or Quality Operations, with progression and regulatory knowledge as described for the GJL levels:
  • 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

Skills

• 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.

Education

• Bachelor's degree with preferred area of study in biology, biochemistry, chemistry, or other science degree.

Additional Requirements

• 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.