Regulatory & Quality (Life Sciences)·Confirmed live in the last 24 hours·
Full-timeSaco, ME, USA
About the Job
Requirements
A bachelor's degree in Life Sciences and at least 5 years of experience in a cGMP-regulated environment, including at least 2 years in Quality Assurance.
Strong written and verbal communication skills and proficiency in Microsoft Suite.
Excellent proofreading skills and strong attention to detail.
Ability to manage multiple priorities in a fast-paced, changing environment and meet challenging deadlines.
A strong work ethic, a team-oriented mindset, and willingness to learn.
Ability to communicate clearly and constructively.
Ability to lift up to 30 pounds.
Responsibilities
Review and approve Quality Management System documentation, including 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 internal, customer, and regulatory audits.
Maintain MMQCI’s ISO 13485 certification.
Write SOPs and train key personnel as needed to support all departments.
Assist others and perform additional tasks as assigned.
Desired Qualifications
Knowledge of current GMP regulations, ISO 13485, and In Vitro Diagnostic Regulation (IVDR).
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 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
The pay range for this position is $27.88 to $53.85/hour
Interested in joining our team? Please submit both a resume and cover letter with your application for consideration.
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!