Regulatory Compliance Stability Specialist – Biological
About the position
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. Under limited supervision, assist/perform Laboratory Information Management System (LIMS) stability module functions, annual stability requirement lot selection, facilitate stability sample management/distribution, and data collection/collation. Hours: 1st Shift. Overtime and weekend work may be required.
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.
Requirements
• 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
Nice-to-haves
• Thorough knowledge of USDA regulatory requirements associated with stability.
• Experience with Biological Manufacturing and/or Biological Laboratories
Benefits
• 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
Apply tot his job
Apply To this Job
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. Under limited supervision, assist/perform Laboratory Information Management System (LIMS) stability module functions, annual stability requirement lot selection, facilitate stability sample management/distribution, and data collection/collation. Hours: 1st Shift. Overtime and weekend work may be required.
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.
Requirements
• 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
Nice-to-haves
• Thorough knowledge of USDA regulatory requirements associated with stability.
• Experience with Biological Manufacturing and/or Biological Laboratories
Benefits
• 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
Apply tot his job
Apply To this Job