(Archived) QA Compliance Specialist – Raw Materials

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.

Benefits Include:

Great Health Benefits from day 1!

4 weeks accrued paid vacation and 13 paid holidays

401(k) match with company profit sharing

Tuition reimbursement

Position Summary

The QA Compliance Specialist interacts directly with Zoetis’s internal customers for disposition of raw materials. These interactions require frequent collaboration with these internal customers to make decisions regarding supplier materials. Using a deep understanding of cGMP documentation, the Specialist will review material release documentation as well as other ancillary attachments such as vendor technical documentation, certificate of analysis/compliance and confirmatory test results, in order to ensure the timely release of raw material for production. They will provide input on issues within their area of responsibility to management for resolution and/or improvements. The Specialist will also be expected to perform all associated SAP transactions as part of the release as well as other Quality functions within SAP.

Position Responsibilities

• Review, manage and ensure compliance with GMP regulations for raw materials pertaining to commercial manufacturing
  • Review material release documentation such as vendor technical documentation, certificate of analysis/compliance and confirmatory test results, for timely release of raw material for production
  • Management of Zoetis Manufacturing Controlled Documents, i.e., Raw Material Specifications
  • Perform visual description testing
  • Manage archive samples
  • Perform all associated SAP transactions as part of the release function
  • Provide input on issues to management for resolution and/or improvements
  • SME for USP/EP compendial testing
  • Develop Sampling Plans to ensure adequate sample quantities for testing and archiving

• Work with project teams to on-board new/replacement raw materials
• Maintain a thorough knowledge of APHIS/USDA/FDA/EMEA regulatory requirements associated with the testing and release of raw materials and their impact on the manufacturing of veterinary biological and pharmaceutical products
• 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

Education and Experience

• Bachelor’s degree preferred with preferred area of study in biology, biochemistry, chemistry, or other science degree
• Minimum 3 years relevant experience
  • Job level based on years of relevant experience and working regulatory knowledge:
    • For the GJL 040-2 level
      • Minimum 3-5 years of progressive experience at the OTE Lead level or above, in Manufacturing or Quality Operations
    • For the GJL 060-1 level
      • Greater than 3 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.

Technical Skills and Competencies

• 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
• Experience in testing and test selection for raw materials
• Significant knowledge of GMP regulations for commercial manufacturing as relevant to raw materials
• Experience supporting technical transfers
• 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

Physical Position Requirements

The position is primarily office based, with a significant amount of time spent sitting/working at a computer and processing paperwork. Some lifting is required, and applicant needs to hold a valid driver’s license. Periodic weekend work and off-shift work may be required.