Quality Control Team Lead
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!
Who We Are & What We Do...
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.
What You'll Do...
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.
Key Responsibilities & Expected Outcomes
- 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.
Knowledge, Skills, & Abilities for Success
- 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.
- Proficiencyin Microsoft Word, Excel, and PowerPoint.
Minimum Qualifications
- Education: BA/BS in a scientific discipline.
- Experience: Experience with laboratory quality management systems.
• Viral/Influenza experience is a plus. - Clearance: Ability to obtain/maintain a public trust clearance as needed.
Preferred Qualifications
- Education: Certified Quality Auditor (CQA) certification or equivalent.
- Experience: Additional experience with diagnostics development, QC testing, or regulatory submissions.
- Clearance: CDC public trust clearance.
Work Environment
- Environment: Work will be performed in a climate controlled office or laboratory setting
STI Federal is an Equal Employment Opportunity Employer. We are committed to creating a diverse and inclusive workplace. Qualified applicants are considered for employment regardless of age, disability, ethnicity/race, national origin, religion, gender, gender identity, sexual orientation, or veteran status. Native American preference applies when candidates meet qualifications equally.
STI Federal participates in the Electronic Employment Verification Program. Learn more about E-Verify.
