The Role
Supports quality assurance and regulatory compliance within an ISO 13485 quality system. Reviews QMS documentation, investigates material review notifications, develops CAPA plans, authorizes process and equipment validations, assists with audits, maintains ISO certification, writes SOPs, and trains personnel. Requires experience in cGMP-regulated environments, strong attention to detail, communication skills, and the ability to manage priorities in a fast-paced diagnostic company.
Summary Generated by Built In
Ensure Quality & Compliance as Our Next QA/RA Specialist!
The Quality Assurance/Regulatory Affairs Specialist plays a key role in supporting quality assurance activities and ensuring compliance with applicable regulatory requirements. Reporting to the Manager of QA/RA, this position is responsible for maintaining policies and managing procedures that support MMQCI’s Quality System in alignment with ISO 13485 standards.
The ideal candidate brings experience working within an ISO 13485-regulated environment and is comfortable supporting and maintaining quality systems. This role offers the opportunity to quickly build expertise while working in a collaborative environment.
What You Will Get to Do
Required Skills & Experience
Why You’ll Love Working Here
Benefits We Offer
Get to know the MMQCI team!
https://www.mmqci.com/about/employee-spotlight/employee-spotlight.html
Maine Molecular Quality Controls, Inc. (MMQCI) designs, develops, manufactures, and sells unique quality control products used by hospital laboratories and manufacturers to monitor the accuracy of tests for genetic, oncologic, and infectious diseases. MMQCI has proprietary 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.
MMQCI is conveniently located in beautiful southern coastal Maine, minutes from the Maine Turnpike, Portland International Jetport, and less than 2 hours from Boston. Close by are fabulous Portland restaurants, sandy beaches, and a plentiful supply of Maine lobsters! Many terrific outdoor activities are easily accessible including hiking, biking, kayaking, fishing, skiing and snowshoeing. We’re in a state-of-the-art facility, located in Saco, right next to the Eastern Trail. Come join us!
Interested in joining our team? Please submit both a resume and cover letter with your application for consideration.
The Quality Assurance/Regulatory Affairs Specialist plays a key role in supporting quality assurance activities and ensuring compliance with applicable regulatory requirements. Reporting to the Manager of QA/RA, this position is responsible for maintaining policies and managing procedures that support MMQCI’s Quality System in alignment with ISO 13485 standards.
The ideal candidate brings experience working within an ISO 13485-regulated environment and is comfortable supporting and maintaining quality systems. This role offers the opportunity to quickly build expertise while working in a collaborative environment.
What You Will Get to Do
- Review and approve all Quality Management System documentation (i.e. batch records and QC testing) to ensure compliance with QMS certifications and investigations
- Collaborate with departments to investigate Material Review Notifications and develop Corrective and Preventive Action plans
- Independently reviews and authorizes process and equipment validations
- Performs or assists with audits, including internal, customer, and regulatory audits
- Maintains MMQCI’s ISO 13485 certification
- Writes SOPs and trains key personnel as needed to support all departments
- May be called on to assist others and perform additional tasks as assigned
Required Skills & Experience
- Bachelor’s degree in Life Sciences with 5+ years’ experience in a cGMP-regulated environment, including at least 2 years in Quality Assurance
- Knowledge of current GMP regulations, ISO 13485, and In Vitro Diagnostic Regulation (IVDR) is preferred
- Strong written and verbal communication skills; proficient in Microsoft Suite
- Excellent proofreading skills with strong attention to detail
- Ability to manage multiple priorities in a fast-paced, changing environment and meet challenging deadlines
- Strong work ethic, team-oriented mindset, and willingness to learn
- Ability to communicate clearly and constructively
- Must be able to lift up to 30 lbs
Why You’ll Love Working Here
- Opportunity to make a meaningful impact within a growing diagnostic company
- Collaborative, mission-driven team environment
- Competitive compensation and benefits
Benefits We Offer
- Medical, dental, and vision insurance
- 401(k) retirement savings plan
- Company profit sharing program
- Paid time off, including vacation, holidays, and sick leave
- Paid Parental Leave Program
Get to know the MMQCI team!
https://www.mmqci.com/about/employee-spotlight/employee-spotlight.html
Maine Molecular Quality Controls, Inc. (MMQCI) designs, develops, manufactures, and sells unique quality control products used by hospital laboratories and manufacturers to monitor the accuracy of tests for genetic, oncologic, and infectious diseases. MMQCI has proprietary 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.
MMQCI is conveniently located in beautiful southern coastal Maine, minutes from the Maine Turnpike, Portland International Jetport, and less than 2 hours from Boston. Close by are fabulous Portland restaurants, sandy beaches, and a plentiful supply of Maine lobsters! Many terrific outdoor activities are easily accessible including hiking, biking, kayaking, fishing, skiing and snowshoeing. We’re in a state-of-the-art facility, located in Saco, right next to the Eastern Trail. Come join us!
Interested in joining our team? Please submit both a resume and cover letter with your application for consideration.
Skills Required
- Bachelor's degree in Life Sciences
- 5+ years of experience in a cGMP-regulated environment
- At least 2 years of Quality Assurance experience
- Knowledge of current GMP regulations
- Knowledge of ISO 13485
- Knowledge of In Vitro Diagnostic Regulation (IVDR)
- Strong written and verbal communication skills
- Proficiency with Microsoft Suite
- Excellent proofreading skills and strong attention to detail
- Ability to manage multiple priorities and meet challenging deadlines
- Ability to lift up to 30 pounds
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The Company
What We Do
MMQ & Associates, P.C. is a local accounting firm in Scranton, Pennsylvania, providing accounting, tax, assurance, consulting, internal audit outsourcing, business valuation, bookkeeping, payroll, auditing, and tax-planning services. It serves individuals, businesses, government organizations, and public companies across Northeastern Pennsylvania and neighboring regions, including the Pocono and Bethlehem areas, New York, and New Jersey. The firm emphasizes personal service, professional standards, quality control, client value, and long-term relationships.
