QC Technical Lead
About The Position
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.
Requirements
- 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
Nice To Haves
- experience with JMP software
Responsibilities
- 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
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
