Quality Control Specialist I and II
Chippewa Government Solutions LLC, a Sault Tribe Inc. ("STI Federal") company, is searching for a dynamic and skilled Quality Control Specialist to be a key part of our expanding team!
At STI Federal, we drive growth through strategic governmentcontracting, 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, you will support our Laboratory Quality Management System (LQMS) and help ensure the accuracy, reliability, and compliance of serologic and diagnostic testing workflows. Your work contributes directly to the development and release of high-quality diagnostics, reagents, and laboratory procedures.
Key Responsibilities & Expected Outcomes
- Support the LQMS and comply with CLIA, GLP, GMP, and FDA requirements.
- Monitor assay performance and review quality data to ensure diagnostic methods meet required standards.
- Assist with molecular, serologic, virological, and CLIA certified QC testing.
- Maintain equipment master lists, calibration logs, and maintenance documentation.
- Oversee supply inventory; order and inspect incoming materials under applicable regulatory requirements.
- Support evaluation of new or alternate equipment platforms and biological reagents.
- Maintain and review batch production records, preparation records, and master production files for FDA submissions.
- Assist in developing, editing, and validating Standard Operating Procedures.
- Support activities tied to 510(k) and Emergency Use Authorization (EUA) diagnostic kits.
- Assist with non-conforming event analysis and corrective action processes.
- Participate in internal and partners equality audits (domestic and international).
- Contribute to development of quality control materials and evaluation datasets.
- Comply with and support the program's specimen management policy.
- Maintain staff records and quality-related databases.
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.
- Proficiency with Microsoft Word, Excel, and PowerPoint.
- Knowledge of CLIA, GLP, GMP, and FDA regulatory environments.
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.
