Quality Assurance Specialist

MMQCI; Saco (ME); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Profit sharing

Paid time off

Job summary

MMQCI is seeking a QA/RA Specialist to support quality assurance activities and ensure regulatory compliance. The role reports to the Manager of QA/RA and focuses on maintaining policies and procedures aligned with ISO 13485.

The ideal candidate has ISO 13485 experience, strong communication, and a meticulous attention to detail in a collaborative environment.

Qualifications

• Bachelor’s degree in Life Sciences with 5+ years in a cGMP-regulated environment and at least 2 years in QA
• Knowledge of GMP regulations, ISO 13485, and IVDR is preferred
• Strong written and verbal communication skills and attention to detail
• Ability to manage multiple priorities in a fast-paced setting

Responsibilities

• Review and approve QA/RA documentation to ensure QMS compliance
• Collaborate across departments to investigate MRNs and develop CAPA plans
• Review and authorize process and equipment validations
• Perform or assist with internal, customer, and regulatory audits
• Maintain ISO 13485 certification
• Write SOPs and train personnel as needed
• Support additional tasks as assigned

Skills

cGMP-regulated environment

QA experience

Excellent communication

Proofreading

Multitasking

Teamwork

Education

Bachelor’s degree in Life Sciences

Tools

Microsoft Office

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 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 review and authorize process and equipment validations
• Perform or assist with audits, including internal, customer, and regulatory audits
• Maintain MMQCI’s ISO 13485 certification
• Write SOPs and train 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.