Quality Assurance Associate

Actalent • New Richmond, WI

34d • $21 - $26 • Onsite

About The Position

We are seeking a dedicated Quality Assurance Associate to perform activities related to document control in the manufacturing process of porcine islets and encapsulated islet combination products. This role involves adhering to SOPs and FDA Good Manufacturing Practices, assisting with animal health checks, operating room and necropsy procedures, and maintaining animal care while ensuring strict documentation control in compliance with GLP/GMP regulations.

Requirements

• 1+ years of documentation experience in a regulated environment, preferably in the pharmaceutical or medical device industry.
• 6+ months of experience in animal husbandry.
• Understanding of GMP/GLP regulations and practices.
• Strong communication skills, both written and verbal.
• Comfortable working in a facility that conducts animal research.
• Proficient in Microsoft Programs such as Teams and Office 365.
• Willingness to comply with health and safety requirements of the facility, including biosecurity qualifications.

Nice To Haves

• Bachelor's degree.
• Swine husbandry experience.
• Experience working with large animals.
• Previous experience in an FDA regulated environment.
• Veterinary technician or veterinary assistant certification.

Responsibilities

• Perform document control activities related to manufacturing processes.
• Follow SOPs and FDA Good Manufacturing Practices.
• Assist with animal health checks and operating room procedures.
• Conduct necropsy procedures as needed.
• Maintain animals and ensure compliance with GLP/GMP regulations.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Administrative and Support Services
• Number of Employees: 1,001-5,000 employees