Regulatory Compliance Specialist

1 week ago


Saco, Maine, United States MMQCI Full time
Job Overview

The Quality Assurance/Regulatory Affairs (QA/RA) Associate plays a pivotal role in ensuring MMQCI's Quality System policies and procedures comply with U.S. and international regulations.

Responsibilities
  • Maintain and update MMQCI Quality System documentation to ensure compliance with established procedures and regulatory requirements, including SOPs, Master Batch Records, Change Orders, Material Review Notices, and Corrective and Preventive Actions.
  • Support internal and supplier audits, as well as regulatory and customer audits.
  • Assist in the assembly of Device Master Records for new products.
  • Maintain training documentation for all MMQCI employees.
Requirements
  • Nonsmoker due to product contamination prevention requirements.
  • High School diploma required; Associate degree preferred.
  • At least 1 year working in an office setting.
  • Proficiency with Microsoft Office software (Excel, Word, Outlook).
  • Detail-oriented individual with excellent proof-reading skills.
  • Ability to manage multiple priorities with minimal supervision.
  • Flexible and accustomed to fast-changing priorities.
  • Strong communication and computer skills.
  • Bonus skill: knowledge of current cGMP regulations.
Benefits
  • Medical insurance.
  • Dental insurance.
  • 401(k).
  • Profit sharing plan.
  • Vacation time.
  • Holidays.
  • Sick leave.

$45,000 - $55,000 per annum, depending on experience.



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