QUALITY ASSURANCE/REGULATORY AFFAIRS ASSOCIATE

Quality Assurance/Regulatory Affairs Associate

Maine Molecular Quality Controls, Inc

Saco, Maine

MMQCI is seeking a QA/RA Associate, to be based in their Saco Maine Location

Requirements of the QA/RA Associate:

• •  High School diploma is required. Associate degree preferred.
  • At least 1 year working in an office setting is required.
  • Must be a nonsmoker due to product contamination prevention requirements.
  • Vaccinations for Covid required, and a test within one week including results reported prior to starting work.
  • Proficiency with Microsoft Office software (Excel, Word, Outlook) is required.
  • Detail oriented with the ability to multi-task.
  • Knowledge of current cGMP regulations is considered a “bonus” skill.
  • Knowledge of ISO 13485 and FDA 21CFR 820 is preferred.
  • Excellent proof-reading skills are required.  This will include inspection of documents (small print and symbols) for accuracy without external magnification.
  • Ability to be a good team player, who can adapt quickly to change
  • Good communication skills, written and oral,
  • Able to lift boxes weighing up to 50lbs from standing or squatting position using a step stools or small ladder.

Benefits of the Job:

• • Medical insurance, dental insurance
  • 2 weeks of vacation
  • 11 paid holidays, including 4 Flexible Days
  • 7 paid sick days
  • 401(k) retirement plan
  • Profit-sharing plan
  • Paid parental leave
  • State-of-the-art facility located right next to the Eastern Trail
  • Relaxed and challenging work environment

Responsibilities of the QA/RA Associate:

• • Responsible for activities involving quality assurance and compliance with applicable regulatory requirements.
  • Under the supervision of the Manager of QA/RA, the QA/RA Associate is responsible for assisting the team with the maintenance of MMQCI’s Quality System policies and procedures that ensure quality compliance to U.S and international regulations.
  • Tasks include, but are not limited to, record review, filing, document archiving, and document control activities. MMQCI is looking for a person that will rapidly develop sufficient expertise to function independently with minimal supervision.
  • Supports QA/RA with the maintenance of MMQCI Quality System documentation to ensure compliance with established procedures and regulatory compliance requirements, including, but not limited to, Standard Operating Procedures (SOPs), Master Batch Records, Change Orders (CO), Material Review Notices (MRNs) and Corrective and Preventive Actions (CAPAs), and training.
  • Maintenance of documentation includes record retention activities.
  • Assists with internal and supplier audits.
  • Supports regulatory and customer audits.
  • Assists in the assembly Device Master Records for new products.
  • Maintains training documentation of all MMQCI employees.

MMQCI designs, develops, manufactures, and distributes quality control products to ensure the accuracy of medical laboratory diagnostic testing. MMQCI is passionate about improving patient care and offer a friendly community where employees work together to support their customers.

Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, ancestry, familial status, age, physical or mental disability, pregnancy, sexual orientation, gender identity, genetic information, veteran status, or any other characteristic protected by law.