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Quality Assurance Specialist

MMQCISaco, ME
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Overview

Schedule
Full-time
Career level
Senior-level
Remote
On-site
Benefits
Health Insurance
Dental Insurance
Vision Insurance

Job Description

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 position is responsible for maintaining policies and managing procedures that support MMQCI’s Quality System in alignment with ISO 13485 standards. The ideal candidate brings experience working within an ISO 13485-regulated environment and is comfortable supporting and maintaining quality systems. This role offers the opportunity to quickly build expertise while working in a collaborative environment. What You Will Get to Do 
  • Review and approve all Quality Management System documentation (i.e. batch 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 or assists with audits, including internal, customer, and regulatory audits 
  • Maintains MMQCI’s ISO 13485 certification  
  • Writes SOPs and trains key personnel as needed to support all departments 
  • May be called on to assist others and perform additional tasks as assigned 
Required Skills & Experience
  • Bachelor’s 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, ISO 13485, and In Vitro Diagnostic Regulation (IVDR) is preferred 
  • 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 to lift up to 30 lbs 
Why You’ll Love 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 vision insurance
  • 401(k) retirement savings plan
  • Company profit sharing program
  • Paid time off, including vacation, holidays, and sick leave
  • Paid Parental Leave Program
The pay range for this position is $27.88 to $53.85/hourGet to know the MMQCI team! https://www.mmqci.com/about/employee-spotlight/employee-spotlight.htmlMaine Molecular Quality Controls, Inc. (MMQCI) designs, develops, manufactures, and sells unique quality control products used by hospital laboratories and manufacturers to monitor the accuracy of tests for genetic, oncologic, and infectious diseases. MMQCI has proprietary 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 Maine Turnpike, Portland International Jetport, and less than 2 hours from Boston. Close 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, fishing, skiing and snowshoeing. We’re in a state-of-the-art facility, located in Saco, right next to the Eastern Trail. Come join us! Interested in joining our team? Please submit both a resume and cover letter with your application for consideration.

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FAQs About Quality Assurance Specialist Jobs at MMQCI

What is the work location for this position at MMQCI?
This job at MMQCI is located in Saco, ME, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at MMQCI?
Employer has not shared pay details for this role.
What employment applies to this position at MMQCI?
MMQCI lists this role as a Full-time position.
What experience level is required for this role at MMQCI?
MMQCI is looking for a candidate with "Senior-level" experience level.
What benefits are offered by MMQCI for this role?
MMQCI offers following benefits: Health Insurance, Dental Insurance, Vision Insurance, Paid Holidays, Paid Vacation, Paid Sick Leave, and 401k Matching/Retirement Savings for this position. Actual benefits may vary depending on the employer's policies and employment terms.
What is the process to apply for this position at MMQCI?
You can apply for this role at MMQCI either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.