Quality Control Team Lead
About The Position
Chippewa Government Solutions LLC, a Sault Tribe Inc. (“STI Federal”) company, is searching for a dynamic and skilled Quality Control Team Lead to be a key part of our expanding team! At STI Federal, we drive growth through strategic government contracting, fulfilling our mission to support the Sault Ste. Marie Tribe of Chippewa Indians. Our company reinvests 100% of its profits into tribal businesses or community programs, enhancing the well-being of over 52,000 tribal citizens. Our work empowers federal agencies and strengthens some of the nation’s most critical initiatives, while fostering opportunities for skilled professionals to make a meaningful impact. As a Quality Control Specialist III, you will serve as a lead contributor within the Laboratory Quality Management System (LQMS), performing advanced QC testing, reviewing data, and guiding daytoday team activities. You will help ensure all diagnostics, reagents, and laboratory processes meet stringent quality standards.
Requirements
- Demonstrates a dedication to upholding and enhancing STI Federal’s core values.
- Excels in a collaborative team environment, fostering positive relationships and contributing to shared goals with professionalism and mutual respect.
- Strong knowledge of CLIA, GLP, GMP, and FDA regulatory frameworks.
- Ability to work both independently and collaboratively within a team.
- Excellent verbal and written communication skills, with the ability to organize and interpret large datasets.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- BA/BS in a scientific discipline.
- Experience with laboratory quality management systems.
- Ability to obtain/maintain a public trust clearance as needed.
Nice To Haves
- Viral/Influenza experience is a plus.
- Certified Quality Auditor (CQA) certification or equivalent.
- Additional experience with diagnostics development, QC testing, or regulatory submissions.
- CDC public trust clearance.
Responsibilities
- Lead team members in daily quality control tasks and project deliverables.
- Support implementation and continuous improvement of the LQMS.
- Ensure compliance with CLIA, GLP, GMP, and FDA requirements.
- Update equipment master lists, calibration logs, and maintenance documentation.
- Maintain all quality related records, including batch production, preparation records, and master production files for FDA submission.
- Monitor assay performance and conduct molecular and virological QC testing.
- Analyze quality and validation data for diagnostic methods.
- Perform CLIA certified testing and develop QC/QA materials.
- Support the program’s specimen management policy.
- Maintain supply inventory; order and inspect materials following regulatory guidelines.
- Evaluate new or alternative laboratory equipment and biological reagents.
- Assist with nonconforming event investigations and corrective action initiatives.
- Conduct domestic and international site visits and quality audits at partner facilities.
- Maintain staff records and related databases.
- Assist with developing, editing, and validating Standard Operating Procedures supporting manufacturing and QC processes.
- Support activities associated with 510(k) submissions and Emergency Use Authorization (EUA) diagnostic kits.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
