QC Technical Lead

MMQCI; Saco (ME); On-site; USD 66,000 - 124,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Profit sharing

Paid time off

Parental Leave

Job summary

MMQCI is seeking a Quality Control Technical Lead to oversee and execute QC release testing using complex molecular test systems. You will mentor staff, coordinate testing, and ensure timely QC deliverables in a contamination-controlled lab environment.

The role requires a strong clinical molecular laboratory background, experience with multiple testing platforms, data analysis, CAPA investigations, and adherence to cGMP. Collaboration with R&D and cross-functional teams is essential.

Qualifications

• M.S. or B.S. with molecular biology focus and relevant work experience; MT (ASCP) certification preferred.
• Mastery of a broad array of molecular biology assays across testing platforms with precise pipetting.
• Experience leading project teams and risk assessments.
• Ability to identify questionable data trends and lead root-cause investigations.
• Experience in CLIA, GMP or ISO certified industrial environments.
• Comfort in a clean room with gowning and aseptic technique.

Responsibilities

• Mentor and train others in molecular clinical diagnostic testing methods and QC.
• Perform and coordinate testing for releases, special testing, and investigations with timely results.
• Author and improve QC SOPs.
• Lead data analyses and CAPA projects; investigate customer complaints.
• Coordinate transfer of new products from R&D to QC with cross-functional collaboration.
• Stay current with equipment and methodologies for DNA/RNA testing.
• Summarize data and present findings to stakeholders as needed.
• Adhere to cGMP quality systems and contamination prevention practices.
• Support cross-functional training and culture of quality.

Skills

Molecular biology assays proficiency

Accurate pipetting

Data trend analysis

Root-cause investigations

Project leadership

Statistical methods (JMP)

Clean room / aseptic technique

Excellent communication

Education

M.S. in Biology / Life Sciences with Molecular Biology focus

B.S. in Biology / Life Sciences with Molecular Biology focus and 6+ years experience

Medical Technologist MT (ASCP) certification preferred

Tools

JMP software

Job description

Put Your Technical Expertise to Work in Quality Control!

MMQCI is seeking a Quality Control Technical Lead who enjoys overseeing and executing quality control release testing of MMQCI’s products using a variety of complex molecular test systems, performing statistical data analysis, troubleshooting instrumentation, data trends, and unexpected results.

The Technical Lead is a passionate problem-solver with a strong background in clinical molecular laboratory techniques. Responsibilities also include coordinating schedules, ensuring testing materials are available, and helping ensure QC lab deliverables are completed on time. The Technical Lead maintains a contamination-free lab by ensuring stringent adherence to established protocols, works cross-functionally with a variety of internal teams, and may occasionally interact with customers on technical questions and troubleshooting. This role reports to the Manager of Manufacturing Operations and is expected to work independently with minimal supervision.

What You Will Get to Do

• Use technical expertise in molecular clinical diagnostic testing methods, instrumentation, and quality control principles and practices to mentor and train others


• Performs and coordinates testing of MMQCI products for product releases, special testing, and investigations, while ensuring accurate test results and timelines are met


• Author, review, and continuously improve QC standard operating procedures (SOPs)


• Assists others with data analysis and review and performs QC-related issue/failure investigations, CAPA projects, and testing/evaluation for customer complaints


• Helps coordinate transfer of new products/assays from R&D to QC. Collaborates with R&D and Discovery to establish/implement new test methods and release criteria


• Stays current with equipment, technologies, and methodologies employed in sample preparation and testing of DNA and RNA products


• Summarizes and communicates issues and data. Able to generate concise summary in written communications. Presents data to others as needed


• Follows MMQCI’s quality systems in accordance with current Good Manufacturing Practice (cGMP)


• Helps ensure proper product handling and cross-contamination practices are being followed in the QC area. May include training of cross functional personnel


• Role model to help build a culture that understands and supports MMQCI’s quality plan, the need for accuracy, attention to detail, risk mitigation, contamination prevention, and continuous improvement


• Carefully and consistently follows all MMQCI protocols to protect product integrity, including repetitive cleaning of benches, and donning of gloves, booties, lab coats, facemasks and hairnets and other Personal Protective Equipment (PPE) as appropriate

Required Skills & Experience

• M.S. in Biology / Life Sciences with Molecular Biology focus and 3+ years applicable work experience or B.S. and 6+ years applicable work experience. Applicable work experience would be either molecular diagnostic clinical laboratory or performing testing in a medical device industrial setting. Medical Technologist MT (ASCP) certification is strongly preferred


• Demonstrated mastery of a broad array of molecular biology assays across multiple testing platforms, featuring exceptional lab proficiency/pipetting accuracy


• Proficient in lab techniques supporting molecular biology including accurate pipetting skills


• Exceptional ability to identify questionable data trends or results and successfully lead root-cause investigations


• Experience leading project teams, performing risk assessments, and successfully implementing new laboratory protocols


• Proficiency in statistical techniques applicable to medical devices or patient sample monitoring (experience with JMP software is a plus)


• Experience working with products requiring special handling and work area protocols to prevent contamination. Comfortable in a clean room laboratory environment where gowning and aseptic technique are required


• Good communication skills, written and oral, strong computer skills, excellent mentorship and training skills


• Experience in a CLIA, GMP or ISO certified industrial environment is required


• Must be able to stand for several hours, lift approximately 30 lbs., reach overhead, and be able to climb ladder to reach and put away items on high shelves


• Must have visual acuity to inspect testing materials, well plates, and analyze color coded results

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 $65,500 to $124,000 annually

Get to know the MMQCI team!

https://www.mmqci.com/about/employee-spotlight/employee-spotlight.html

Maine 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 MaineTurnpike, 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,skiingand snowshoeing.We’reina state-of-the-artfacility,locatedin Saco, right next to the Eastern Trail. Come join us!