Quality Assurance Specialist

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! 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! #J-18808-Ljbffr MMQCI-Maine Molecular Quality Controls Inc.