Manufacturing Process Verification Specialist – mAbs 1st Shift
3 weeks ago
About Zoetis
Zoetis is the world's largest manufacturer and supplier of animal pharmaceuticals. Our Lincoln, NE plant has been recognized as one of Nebraska's safest companies, with a long-standing presence in the community.
Job Summary
The Manufacturing Process Verification Specialist will support various activities within media preparation operations, including closing process in SAP, GMP review of batch records, audit of batch records, CAPA, and change management. This role will report directly to the manufacturing team and require presence on the manufacturing floor.
Responsibilities
- Responsible for production batch record GMP review and 100% right first-time goal achievement.
- TECO and COOISPI of batches.
- Indicate change control to corresponding batch records and redline executable batch records.
- Assist with batch record data assembly.
- Responsible for deviation Pareto board update and assist with deviation trending.
- Assist with deviation investigation and write-up (manufacturing and environmental investigations) and change management.
- Responsible for related manufacturing CAPA implementation.
- Participate in daily manufacturing/Quality assurance meeting.
- Train colleagues on GMP documentation and ensure team compliance during execution and throughout review of batch records.
- Act as a liaison and collaborate with manufacturing support groups (quality assurance and mAb technical support) to ensure respect of GMP practice and appropriate CAPA defined.
- Understand, follow, and complete process documentation in support of GMP.
- Assist as needed the production team with production tasks.
- Understand and follow safety policies as it relates to biological and chemical components and equipment to protect personnel and maintain product quality.
Requirements
Relevant BS or equivalent degree required; MA/MS preferred. Preference given to applicants with relevant experience in GMP regulated manufacturing environment.
Technical Skills and Competencies Required
Functional skills:
- Ability to read and follow written directions.
- Ability to communicate effectively both verbally and in writing.
- Ability to think critically.
- Ability to function independently when required.
- Ability to meet deadlines and keep organized methods of tracking standard work.
Technical skills:
- Basic computer skills (Word and Excel).
- Proficiency in SAP.
Ability to troubleshoot.
- Knowledge in GMP environment.
Desirable skills:
- Familiarity with biologic manufacturing process.
- Knowledge in MODA.
- Knowledge in Trackwise.
Physical Position Requirements
Exposure to chemicals, fumes, odors, noise, live steam, temperature fluctuations, biohazards, continuous standing and lifting to a maximum of 50 lbs.
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