Quality Assurance/Regulatory Affairs Specialist I: Molecular
Diagnostic Products

Employer: Maine Molecular Quality Controls, Inc. (MMQCI) designs, develops, manufactures, and
markets unique quality control products used by hospital laboratories to monitor the accuracy of tests
for inherited disease, pharmacogenetics, oncology, and infectious diseases. MMQCI has developed
technologies to stabilize DNA and RNA for use as quality controls and continues to pursue the discovery
of novel techniques useful for the development of new quality control products. We are a small,
growing company that offers a relaxed but challenging work environment.

POSITION TITLE: Quality Assurance/Regulatory Affairs Specialist I

GENERAL SUMMARY:
The Quality Assurance/Regulatory Affairs Specialist I is responsible for activities involving quality
assurance and compliance with applicable regulatory requirements. Under the supervision of the
Manager of QA/RA, the QA/RA Specialist I is responsible for the maintenance of policies, and
management of procedures, that ensure quality compliance to MMQCI’s Quality System, based on
federal Quality System Regulation 21CFR820. The successful candidate is experienced in using and
maintaining a Quality System according to 21CFR820. It is expected that the QA/RA Specialist I will
rapidly develop sufficient expertise to function independently. Maine Molecular is looking for the
person with the energy and experience to step into this vital position in a growing company and grow
along with us.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

1. 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).

2. Works closely with Manufacturing to support and document MRNs and CAPAs.
3. Assists or performs internal audits and supplier audits.
4. Supports FDA and customer audits.
5. Assists in the assembly Device Master Records for new products.
6. Maintains training documentation of all MMQCI employees.

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

1. Education Requirements: Bachelor of Science degree in Life Sciences and at least 5 years of
employment in a cGMP regulated facility and at least 2 years of experience in Quality Assurance.

2. Good communication skills, written and oral, with excellent computer skills including Excel.
3. Excellent proof-reading skills are required.
4. Very detail oriented.
5. Knowledge of current GMP regulations is required.
6. Knowledge of ISO 13485 is preferred.

7. Experience in laboratory medicine is highly preferred.
8. Ability to multi-task in a dynamic environment with changing priorities.
9. Strong work ethic.
10. Ability to meet challenging timelines, in spite of obstacles.
11. Willingness to learn and pitch in as part of team
12. Ability to communicate clearly and constructively to correct non-conforming behaviors and

practices.
13. Must be a nonsmoker due to product contamination prevention requirements.