Quality Assurance Specialist II in Regulatory Affairs
3 weeks ago
Position: Quality Assurance/Regulatory Affairs Specialist II
Company 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 inherited diseases, pharmacogenetics, oncology, and infectious diseases. We pride ourselves on our advanced technologies that stabilize DNA and RNA for quality control applications, and we are committed to the ongoing discovery of novel methodologies to enhance our product offerings. As a small yet expanding organization, we foster a relaxed yet stimulating work atmosphere.
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, reviewing, and analyzing documentation and data. Reporting to the Manager of QA/RA, the Specialist is tasked with the implementation, management, and upkeep of policies and systems that uphold quality compliance in alignment with MMQCI's Quality System, as dictated by 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 who is eager to contribute and grow within our dynamic team.
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).
- Conduct validations of new equipment and processes.
- Assist in performing 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 and international product registrations.
- Prepare and submit FDA pre-submissions, de novo requests, and 510(k) submissions for Class II products.
- Interpret relevant statutes, regulations, and policies for staff, clarifying their implications for product development and manufacturing.
- Stay informed on regulatory trends affecting products and communicate 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 departments to review and approve product labeling, promotional materials, and address non-conformance issues.
- Provide training and presentations on regulatory topics to cross-functional teams.
- Draft SOPs and provide training to key personnel as necessary.
- Perform additional duties as assigned, including monitoring and enhancing the quality system and managing post-market surveillance 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.
- Strong proofreading skills.
- In-depth knowledge of current GMP regulations.
- Detail-oriented with a focus on accuracy.
- Familiarity with ISO 13485 and In Vitro Diagnostic Regulation (IVDR).
- Experience in laboratory medicine is highly preferred.
- Excellent 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 deadlines.
- Willingness to learn and collaborate as part of a team.
- Ability to communicate effectively to address non-conforming practices.
- Must adhere to non-smoking policies to prevent product contamination.
Benefits:
• Medical insurance
• Dental insurance
• 401(k)
• Profit sharing plan
• Vacation
• Holidays
• Sick leave
Location: MMQCI is situated in a prime area, offering access to various outdoor activities and amenities.
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