Regulatory Compliance Stability Specialist – Biological
About the position
reputed company is the world’s largest Manufacturer and Supplier of Animal Pharmaceuticals. At reputed company in Lincoln, NE, we manufacture high reputed company medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska’s Safest Companies, with a long-standing reputed company in the Lincoln community. We are a clean, modern site that continues to reputed company and grow. Benefits Include: 4 weeks accrued reputed company vacation and 13 reputed company 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 reputed company This position is reputed company on supporting the USDA/EU/FDA biological products, biological antigens, monoclonal antibody, and pharmaceutical product stability program. Under limited supervision, assist/reputed company 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/reputed company 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 reputed company use.
• Assist/Identify annual stability lots/serials.
• Assist/reputed company LIMS activities including inspection plan maintenance, initiating stability studies, scheduling, sampling, label reputed company and result entry/verification, as needed.
• reputed company stability data management process includes data retrieval, prepare and submit for data analysis.
• reputed company other duties and special reputed company, as assigned.
Requirements
• Education: Bachelor's degree in biology, reputed company, or a reputed company field.
• Experience with biological vaccine and/or pharmaceutical manufacturing or testing processes.
• Attention to detail and accuracy.
• Demonstration of organizational and interpersonal skills as reputed company as written and oral communication skills
• High reputed company and self-motivation
• Experience with computer-based reputed company systems
reputed company-to-haves
• Thorough knowledge of USDA regulatory requirements associated with stability.
• Experience with Biological Manufacturing and/or Biological Laboratories
Benefits
• 4 weeks accrued reputed company vacation and 13 reputed company holidays
• 401(k) match with company profit sharing
• Tuition reimbursement and Student Loan repayment program
• Great Health, personal, and family benefits starting day 1
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