Regulatory Compliance Manager

4 days ago


Fort Atkinson, Iowa, United States PSC Biotech Full time
Career Opportunities at PSC BiotechPSC Biotech is a dynamic and innovative company, committed to empowering clients' success through expert services, coaching, and development opportunities. Our team of experts spans multiple locations, working together to deliver exceptional results and make a meaningful impact in the industry.

We are seeking an experienced Quality Engineer to join our team, who will provide technical expertise and thorough quality review of validation documentation and corrections. This individual will possess a strong background and understanding of validation processes and procedures, ensuring compliance with industry regulations and standards.

Key Responsibilities:
  • Review and approve validation lifecycle documentation, including commissioning, qualification, validation protocols, reports, records, etc.
  • Provide ongoing technical guidance and expertise, ensuring compliance with industry standards and regulations.
  • Review and approve specified documentation, including technical specifications, vendor-supplied test results, design qualification, test plans, RTM, changes, and exceptions.
  • Offer guidance on interpretation and application of specified requirements.
  • Effectively communicate project updates and milestones with stakeholders.
  • Provide suggestions on technical aspects for improvement.
  • Ensure efficient follow-up to cross-functional departments and QA teams.


Requirements
  • Bachelor's degree in a scientific or engineering discipline.
  • 5+ years of quality engineering experience in the pharmaceutical and/or medical device industry.
  • Strong understanding of regulatory requirements.
  • Excellent attention to detail and quality background to provide thorough review and approval of validation lifecycle documentation.
  • Strong analytical and problem-solving skills.
  • Ability to work independently and lead validation projects.


BenefitsWe offer a comprehensive benefits package, including medical, dental, and vision coverage, 401(k) matching, education assistance, pet insurance, and discounted fitness memberships. Our estimated annual salary range is $95,000-$130,000, depending on experience.

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