Requirements of the QA/RA Specialist I:

• Bachelor of Science degree in Life Sciences and 5+ years of employment in a cGMP regulated facility and 2+ years of experience in Quality Assurance/Regulatory Affairs
• Must be a nonsmoker due to product contamination prevention requirements.
• Vaccinations for Covid required, and a test within one week including results reported prior to starting work.
• Knowledge of current GMP regulations is required.
• Knowledge of ISO 13485 is preferred.
• Strong skill in utilizing Microsoft Office software (Excel, Word, Outlook) is required.
• Excellent proof-reading skills are required.
• Highly detail oriented with the ability to multi-task in a changing environment.
• Experience in laboratory medicine is highly preferred.
• Good communication skills, written and oral.
• Technical writing skills preferred.
• Ability to meet challenging timelines, despite obstacles.
• Willingness to learn and pitch in as part of team.
• Capable of rapidly developing sufficient expertise to function independently.

Benefits of the Job:

• Medical insurance, dental insurance
• 2 weeks of vacation
• 11 paid holidays, including 4 Flexible Days
• 7 paid sick days
• 401(k) retirement plan
• Profit-sharing plan
• Paid parental leave
• State-of-the-art facility located right next to the Eastern Trail
• Relaxed and challenging work environment

Responsibilities of the QA/RA Specialist I:

• Is responsible for activities involving quality assurance and compliance with applicable regulatory requirements.
• Maintains policies, and management of procedures, that ensure quality compliance to MMQCI’s Quality System, based on federal Quality System Regulation 21CFR820.
• Maintains MMQCI Quality System documentation to ensure compliance with established procedures and regulatory compliance requirements, including, but not limited to, Standard Operating Procedures (SOPs), Master Batch Records, Change Orders, Material Review Notices (MRNs) and Corrective and Preventive Actions (CAPAs).
• Works closely with Manufacturing to support and document MRNs and CAPAs.
• Assists or performs internal and supplier audits.
• Supports regulatory and customer audits.
• Assists in the assembly Device Master Records for new products.
• Maintains training documentation of all MMQCI employees.