Quality Assurance Specialist
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Job Location:
Monthly Salary:
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
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 MMQCIs 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
Required Skills & Experience
WhyYoullLove Working Here
Benefits We Offer:
Medical dental and visioninsurance
401(k)
Profit Sharing Plan
Vacation
Holidays
Sick leave
Get to know the MMQCI team!
Molecular Quality Controls Inc. (MMQCI) designs develops manufactures and
markets unique quality control products used by hospital laboratories tomonitorthe accuracy of tests for inherited disease pharmacogenetics oncology and infectious diseases. MMQCI has developed 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 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 fishingskiingand state-of-the-artfacilitylocatedin Saco right next to the Eastern Trail. Come join us!
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 MMQCIs 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 ( 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
- MaintainsMMQCIsISO13485certification
- WritesSOPsandtrainskeypersonnel as needed to support all departments
- May be called on toassistothers and performadditionaltasks as assigned
Required Skills & Experience
- Bachelors 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
WhyYoullLove 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 visioninsurance
401(k)
Profit Sharing Plan
Vacation
Holidays
Sick leave
Get to know the MMQCI team!
Molecular Quality Controls Inc. (MMQCI) designs develops manufactures and
markets unique quality control products used by hospital laboratories tomonitorthe accuracy of tests for inherited disease pharmacogenetics oncology and infectious diseases. MMQCI has developed 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 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 fishingskiingand state-of-the-artfacilitylocatedin Saco right next to the Eastern Trail. Come join us!
Required Experience:
Manager
