Quality Assurance Specialist

MMQCI-Maine Molecular Quality Controls Inc.; Saco (ME); On-site; USD 39,000 - 74,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement savings plan

Company profit sharing program

Paid time off including vacation, plus

Job summary

MMQCI, a Southern Maine diagnostics company, is seeking a QA/RA Specialist to support quality assurance activities and regulatory compliance within an ISO 13485 environment. Reporting to the QA/RA Manager, you will maintain policies and procedures that keep MMQCI's Quality System aligned with standards and inspections.

The role offers rapid exposure to quality systems, audits, CAPA, document control, SOPs, and cross-department collaboration.

Qualifications

• Bachelor’s degree in Life Sciences with 5+ years in a cGMP-regulated environment, including at least 2 years in Quality Assurance.
• Knowledge of GMP regulations, ISO13485, and 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 environment.

Responsibilities

• Review and approve all QMS documentation (e.g., batch records and QC testing) to ensure compliance with QMS standards.
• Collaborate with departments to investigate Material Review Notifications and develop CAPA plans.
• Independently review and authorize process and equipment validations.
• Perform or assist with audits (internal, customer, regulatory).
• Maintain MMQCI’s ISO13485 certification.
• Write SOPs and train key personnel as needed.

Skills

Strong communication

Attention to detail

Multi-tasking

Team collaboration

Willingness to learn

Clear communication

Education

Bachelor's degree in Life Sciences

Tools

Microsoft Suite

Job description

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 positionis responsible formaintainingpolicies and managing procedures that support MMQCI’s Quality System in alignment with ISO 13485standards. The ideal candidate brings experience working within an ISO 13485-regulated environment and is comfortable supporting andmaintainingquality systems. This role offers the opportunity to quickly buildexpertisewhile 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 orassistswith audits, including internal, customer, and regulatory audits

• MaintainsMMQCI’sISO13485certification

• WritesSOPsandtrainskeypersonnel as needed to support all departments

• May be called on toassistothers and performadditionaltasks 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, ISO13485, and InVitroDiagnosticRegulation(IVDR)ispreferred

• 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 tolift upto 30lbs

WhyYou’llLove 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

The pay range for this position is $27.88 to $53.85/hour
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 MaineTurnpike, 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,skiingand snowshoeing.We’reina state-of-the-artfacility,locatedin Saco, right next to the Eastern Trail. Come join us!