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. The Lead may also assist with coordinating QC department schedules and timelines, planning ahead to ensure critical assay reagents are available, and upholding aseptic laboratory environments through coaching and training to established protocols.
This individual works cross-functionally with a variety of internal teams and may on occasion interact with customers on technical questions and troubleshooting. This role reports to the Manager of Manufacturing Operations and is expected to be self-directed and work with limited supervision.
What You Will Get to Do- Applies technical expertise in molecular clinical diagnostic testing and thorough understanding of methodologies, instrumentation, and quality control principles and practices to serve as the technical resource and trainer for the QC team. Performs and documents testing of MMQCI products, including routine, investigative, and special request testing, with accuracy and efficiency. Meets tight deadlines while interpreting, summarizing, and presenting data as needed.
- Troubleshoots unexpected testing results quickly and provides guidance to others in resolving issues. Identifies root causes, applies statistical tools effectively, develops corrective action plans, and collaborates cross-functionally to investigate and solve problems resolve issues.
- Maintains QC testing schedules with input from other teams. Manages daily work flow and adapts to changing priorities to achieve on-time delivery of products. Incorporates product handling needs and cross contamination risk abatement into schedules. Ensures materials/supplies are on hand for testing.
- Assists others with data analysis and review and performs QC-related issue/failure investigations, CAPA projects, and testing/evaluation for customer complaints
- Author, review, and continuously improve QC standard operating procedures (SOPs)
- Follows MMQCI’s quality systems in accordance with current Good Manufacturing Practice (cGMP)
- Technical mentor to various teams, clarifies work procedures, performs and tracks training of team, ensures area adheres to MMQCI quality systems
- Coordinates transfer of new products/assays from R&D to QC. Collaborates with R&D and Discovery to establish/implement new test methods. Sets up associated systems for new products to be run in the QC area
- Applies in depth understanding of technologies, assays and equipment to write and improve QC Standard Operating Procedures (SOPs). Tests SOP edits/ improvements.
- Leads QC area improvements while managing risks. Works cross functionally to implement improvements
- Stays up to date with equipment, technologies and methodologies employed in the sample preparation and testing of DNA and RNA products
- 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’s 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 as appropriate
- May be called upon to perform other support functions and to assist other areas (Manufacturing, Production, R&D, Technical Operations) as needed
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 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.Powered by JazzHR