Regulatory Compliance Stability Specialist - Biological

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

This position is focused on supporting the USDA/EU/FDA biological products, biological antigens, monoclonal antibody, and pharmaceutical product stability program.

Hours: 1st Shift. Overtime and weekend work may be required.

Position Responsibilities

Assist/perform stability support activities that may include:

• Preparation, scheduling, and labeling of stability samples for storage, testing and disposal.
• Maintain stability chambers, coolers, and freezers.
• Assist/prepare stability protocols.
• Prepare reports and/or summaries for internal and external use.
• Assist/Identify annual stability lots/serials.
• Assist/perform LIMS activities including inspection plan maintenance, initiating stability studies, scheduling, sampling, label generation and result entry/verification, as needed.
• Perform stability data management process includes data retrieval, prepare and submit for data analysis.
• Perform other duties and special projects, as assigned.

Education and Experience

• Education: Bachelor's degree in biology, chemistry, or a related field.
• Experience with biological vaccine and/or pharmaceutical manufacturing or testing processes.
• Attention to detail and accuracy.
• Demonstration of organizational and interpersonal skills as well as written and oral communication skills
• High integrity and self-motivation
• Experience with computer-based Quality systems

Preferred Qualifications:

• Thorough knowledge of USDA regulatory requirements associated with stability.
• Experience with Biological Manufacturing and/or Biological Laboratories

Physical Position Requirements

• Computer based position with stability sample handling.
• Hybrid position
• May require occasional evening or weekend work to meet project deadlines.

Physical Requirements:

Position requires sitting, standing, and walking

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.