Quality Assurance/Regulatory Affairs Specialist I: Molecular Diagnostic Products

Maine Molecular Quality Controls, Inc

Saco, Maine

MMQCI is seeking a QA/RA Specialist 1, to be based in the Saco Maine

Requirements of the QA/RA Specialist I:

· Bachelor of Science degree in Life Sciences and 5 years of employment in a cGMP regulated facility and 2 years of experience in Quality Assurance/Regulatory Affairs

· 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.

· Knowledge of current GMP regulations is required.

· Knowledge of ISO 13485 is preferred.

· Strong skill in utilizing Microsoft Office software (Excel, Word, Outlook) is required.

· Excellent proof-reading skills are required.

· Highly detail oriented with the ability to multi-task in a changing environment.

· Experience in laboratory medicine is highly preferred.

· Good communication skills, written and oral.

· Technical writing skills preferred.

· Ability to meet challenging timelines, despite obstacles.

· Willingness to learn and pitch in as part of team.

· Capable of rapidly developing sufficient expertise to function independently.

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 Specialist I:

· Is responsible for activities involving quality assurance and compliance with applicable regulatory requirements.

· Maintains policies, and management of procedures, that ensure quality compliance to MMQCI’s Quality System, based on federal Quality System Regulation 21CFR820.

· Maintains 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, Material Review Notices (MRNs) and Corrective and Preventive Actions (CAPAs).

· Works closely with Manufacturing to support and document MRNs and CAPAs.

· Assists or performs 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.

NO PHONE CALLS OR RECRUITERS, PLEASE

MMQCI is an 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.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person

Application Question(s):

• What is your personal email address?
• Are you eligible to work in the US?
• Are you currently residing in Maine?

Work Location: In person