Process Verification Specialist – mAbs

Zoetis • Lincoln, NE

7d • Onsite

About The Position

The Process Verification Specialist (PVS) will be responsible for supporting various activities within mAb operations at the Lincoln Zoetis site including, but not limited to, closing of lots in SAP, GMP review of the batch records, audit of the batch records, CAPA, and change management documentation. PVS will assist in area deviations when required to streamline executables and provide detailed summaries of floor events for manufacturing investigations. The candidate selected will instill a GMP culture by understanding, following, and completing process documentation in accordance with site policies and procedures. The PVS will participate in the weekend work rotation. PVS will work with QA to ensure area compliance with internal and external regulatory requirements. Area adherence to site safety policy and standards for a safe workplace are essential and will be upheld by the selected candidate. Hours: 1st shift, to be set between 7am to 7pm by the mAb leadership team (M-F, 8 hrs/day, minimum of 40 hrs/week). Position requires some weekend work and is eligible for the mAbs on call rotation.

Requirements

• Ability to read and follow written directions.
• Ability to communicate effectively and efficiently both verbally and in writing.
• Ability to think critically.
• Ability to function independently when required.
• Ability to adapt to manufacturing needs as they occur.
• Basic computer skills (Word and Excel)
• Proficiency in SAP and ETS.
• Ability to troubleshoot and think of creative solutions.
• Familiarity with a GMP Environment.
• BS in Biological sciences, MA/MS preferred.
• Candidate with high school diploma and relevant experience may be considered.

Nice To Haves

• Familiarity with biologic manufacturing process.
• Knowledge in MODA, LIMS, SAP, ETS, and databasing.
• Capable of becoming an effective trainer.

Responsibilities

• Assist with batch record data assembly.
• Provide deviation pareto board updates and assist with deviation trending.
• Assist with deviation investigation and write-up (manufacturing and environmental investigations)
• Assist with change management.
• Support 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 the batch records.
• Track right-first time compliance.
• 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.
• Understand and follow safety policies as it relates to biological and chemical components and equipment to protect personnel and maintain product quality.
• Provide production floor assistance when needed.

Benefits

• $500 Sign on Bonus
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees