Overview
Quality Engineer I Jobs in Cottage Grove, WI at Johnson Health Tech North America Inc
The Quality Assurance (QA) Specialist will ensure compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and regulatory requirements specific to radiopharmaceuticals, including U.S. FDA and relevant nuclear regulatory bodies, for the radiopharmaceutical manufacturing and distribution processes in the organization.
Description
Key Responsibilities:
Implement and maintain quality systems in compliance with GMP/GDP regulations for radiopharmaceuticals.
Perform quality review and release of batch records, including radiochemical testing data and sterility results.
Support validation activities (process, cleaning, equipment, and software) and review associated documentation.
Supports internal and external audits and inspections by regulatory authorities and customers for the Rochester site in coordination with the Manager, Supplier Quality.
Ensure timely resolution of deviations, CAPAs, and change controls.
Participate in supplier qualification and raw material assessments.
Monitor environmental conditions in production and QC testing areas, including radiation safety compliance.
Maintain and update SOPs, work instructions, and training materials.
Provide quality support for technology transfers, new product introductions, and continuous improvement initiatives.
Performs other duties as assigned.
Qualifications:
Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmacy, or a related scientific discipline (advanced degree preferred).
Minimum of 2–5 years of experience in quality assurance/control in a GMP-regulated environment; radiopharmaceutical experience strongly preferred.
Knowledge of regulations such as 21 CFR Part 210/211, USP <825>, EU GMP Annex 3, and radiation safety standards.
Experience with aseptic manufacturing and sterile product handling.
Strong analytical thinking, attention to detail, and problem-solving abilities.
Effective communication skills and ability to work cross-functionally.
Familiarity with Quality Management Systems (QMS) and electronic documentation platforms.
Ability to work in a cleanroom and sterile compounding environment, adhering to strict health and hygiene standards to ensure the safety and quality of drug products.
Must report any health conditions (e.g., rashes, active infections) that could impact product integrity or contamination risks.
Chronic health conditions that prevent long-term performance of essential job functions may require evaluation and could affect employment status.
Proper garbing and personal hygiene must be maintained at all times when in the cleanroom or compounding areas.
THE FINE PRINT:
The salary range in Minnesota is $70,000 – $90,000 per year. Please note that compensation may vary outside of this range depending on several factors, including but not limited to a candidate’s qualifications, skills, competencies, experience, and location.
Benefit packages for this role include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options (depending on the plan chosen), and 401k retirement account access with employer matching. Team members in this role are also entitled to paid sick leave and/or other paid time off in
compliance with applicable law.
This job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks, and duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied
contract of employment; employment remains “at-will”.
Nucleus RadioPharma is an equal opportunity employer and believes everyone deserves respect, dignity, and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
Salary
$70,000 – $90,000 per year
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Title: Quality Engineer I
Company: Johnson Health Tech North America Inc
Location: Cottage Grove, WI
