Regulatory Compliance Specialist
1 week ago
The Quality Assurance/Regulatory Affairs (QA/RA) Associate plays a pivotal role in ensuring MMQCI's Quality System policies and procedures comply with U.S. and international regulations.
Responsibilities- Maintain and update MMQCI Quality System documentation to ensure compliance with established procedures and regulatory requirements, including SOPs, Master Batch Records, Change Orders, Material Review Notices, and Corrective and Preventive Actions.
- Support internal and supplier audits, as well as regulatory and customer audits.
- Assist in the assembly of Device Master Records for new products.
- Maintain training documentation for all MMQCI employees.
- Nonsmoker due to product contamination prevention requirements.
- High School diploma required; Associate degree preferred.
- At least 1 year working in an office setting.
- Proficiency with Microsoft Office software (Excel, Word, Outlook).
- Detail-oriented individual with excellent proof-reading skills.
- Ability to manage multiple priorities with minimal supervision.
- Flexible and accustomed to fast-changing priorities.
- Strong communication and computer skills.
- Bonus skill: knowledge of current cGMP regulations.
- Medical insurance.
- Dental insurance.
- 401(k).
- Profit sharing plan.
- Vacation time.
- Holidays.
- Sick leave.
$45,000 - $55,000 per annum, depending on experience.
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Regulatory Compliance Specialist
1 week ago
Saco, Maine, United States MMQCI Full timeJob Title: Regulatory Compliance SpecialistOverviewMaine Molecular Quality Controls, Inc. (MMQCI) designs, develops, manufactures, and markets quality control products for hospital laboratories to monitor test accuracy for inherited disease, pharmacogenetics, oncology, and infectious diseases.Estimated Salary: $80,000 - $110,000 per year based on location...
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Regulatory Compliance Officer
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Regulatory Compliance Specialist
1 week ago
Saco, Maine, United States MMQCI Full timeThe estimated salary for this role is $45,000 - $65,000 per year.Job DescriptionThis position involves working in a dynamic environment with minimal supervision. The successful candidate will assist the team in maintaining quality compliance with U.S. and international regulations. Key responsibilities include:Maintaining MMQCI's Quality System documentation...
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Saco, Maine, United States MMQCI Full timeSalary and BenefitsThe estimated annual salary for this position is $80,000 - $100,000, depending on experience.Maine Molecular offers a comprehensive benefits package, including medical insurance, dental insurance, 401(k), profit sharing plan, vacation, holidays, and sick leave.About the JobWe are looking for a highly skilled Quality Assurance/Regulatory...
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Compliance and Quality Manager
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