Regulatory Affairs and Quality Control Specialist II
3 weeks ago
Position: Quality Assurance/Regulatory Affairs Specialist II
Company Overview:
Maine Molecular Quality Controls, Inc. (MMQCI) is dedicated to the design, development, and manufacturing of innovative quality control products utilized by hospital laboratories for the accurate monitoring of tests related to inherited diseases, pharmacogenetics, oncology, and infectious diseases. Our company is committed to advancing technologies that stabilize DNA and RNA for quality control applications and is continuously exploring novel methods for developing new quality control solutions. We pride ourselves on being a small, dynamic organization that fosters a relaxed yet stimulating work environment.
Position Summary:
The Quality Assurance/Regulatory Affairs Specialist II plays a crucial role in overseeing quality assurance activities and ensuring compliance with relevant regulatory standards. This position involves conducting audits, analyzing data, and reviewing documentation. Reporting to the Manager of QA/RA, the Specialist II will implement, manage, and maintain policies and systems that uphold compliance with MMQCI's Quality System, adhering to federal Quality System Regulation 21CFR820. The ideal candidate will possess a robust background in the in vitro diagnostic industry and demonstrate proficiency in maintaining a Quality System in accordance with 21CFR820. We seek an individual with the enthusiasm and expertise to thrive in this essential role within our growing organization.
Key Responsibilities:
- Review and approve all quality system documentation to ensure adherence to established procedures and regulatory standards, including Master Batch Records, Standard Operating Procedures (SOPs), Change Orders, Material Review Notices (MRNs), and Corrective and Preventive Actions (CAPAs). Collaborate with various departments to investigate MRNs and establish CAPAs addressing root causes.
- Evaluate and approve validations for new equipment and processes.
- Assist in or conduct internal and supplier audits.
- Support FDA and customer audits.
- Compile Device Master Records for new products.
- Oversee training documentation for all employees.
- Maintain ISO 13485 certification and contribute to Technical Files for CE marking of products while managing international product registrations.
- Prepare and submit FDA pre-submissions, de novo requests, and 510(k) submissions for Class II products, ensuring proper FDA registrations are maintained.
- Interpret regulations, policies, and guidance for staff, clarifying their implications for product development, manufacturing, and marketing.
- Stay informed on regulatory trends affecting products, assessing and communicating their impact to QA/RA teams and product development.
- Participate in and potentially lead internal, customer, FDA, and ISO audits.
- Collaborate with QA/RA and other staff to review and approve product labeling changes, promotional materials, non-conforming product rework, CAPA closures, customer complaint resolutions, and Medical Device Reports (MDR).
- Provide training or presentations on various regulatory topics to cross-functional teams.
- Draft SOPs and train key personnel as necessary.
- Perform additional duties as assigned, including monitoring and enhancing the quality system and managing post-market surveillance, reporting, and recalls.
Qualifications:
- Bachelor's degree in Life Sciences with a minimum of 5 years of experience in a cGMP regulated environment and at least 2 years in Quality Assurance.
- Exceptional proofreading skills.
- Comprehensive knowledge of current GMP regulations.
- Detail-oriented with a strong focus on accuracy.
- Familiarity with ISO 13485 standards.
- Understanding of In Vitro Diagnostic Regulation (IVDR).
- Experience in laboratory medicine is highly desirable.
- Strong written and verbal communication skills, with proficiency in computer applications including Excel.
- Able to manage multiple tasks in a fast-paced environment with shifting priorities.
- Demonstrated strong work ethic and ability to meet challenging deadlines.
- Willingness to learn and contribute as part of a team.
- Ability to communicate effectively to address non-conforming behaviors and practices.
- Must be a non-smoker due to contamination prevention requirements.
Benefits:
• Medical insurance
• Dental insurance
• 401(k)
• Profit sharing plan
• Vacation
• Holidays
• Sick leave
Location: MMQCI is situated in a picturesque area, providing easy access to various amenities and outdoor activities.
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Saco, Maine, United States MMQCI Full timeJob OverviewPosition: Quality Assurance/Regulatory Affairs Specialist IICompany Overview:Maine Molecular Quality Controls, Inc. (MMQCI) is dedicated to the design, development, manufacturing, and marketing of innovative quality control solutions utilized by hospital laboratories. Our products are essential for ensuring the accuracy of tests related to...
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Saco, Maine, United States MMQCI Full timeJob OverviewPosition: Quality Assurance/Regulatory Affairs Specialist IICompany Overview:Maine Molecular Quality Controls, Inc. (MMQCI) is a pioneering organization focused on the design, development, and manufacturing of innovative quality control solutions for hospital laboratories. Our products are essential for ensuring the accuracy of tests related to...
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