QC Lead Technician
About the Role
The QC Lead Technician is a key technical contributor within the Clinical Chemistry and Immunoassay Reagent Testing group, responsible for performing and coordinating Quality Control testing to support the timely release and continued monitoring of diagnostic reagent products. This position performs testing throughout the product lifecycle, including in-process, final kit/release, and ongoing stability testing, while serving as a technical resource for the laboratory. The QC Lead Technician coordinates testing activities and priorities, leads laboratory investigations, troubleshoots instrumentation and assay performance issues, and mentors junior team members.
Responsibilities
- Perform and coordinate Quality Control testing for diagnostic reagent products.
- Conduct testing throughout the product lifecycle, including in-process, final kit/release, and stability testing.
- Serve as a technical resource for the laboratory.
- Coordinate testing activities and priorities.
- Lead laboratory investigations and troubleshoot instrumentation and assay performance issues.
- Mentor junior team members.
Requirements
- Associate's or Bachelor's degree in Chemistry, Biochemistry, Biology, Medical Laboratory Science, or a related scientific discipline, or an equivalent combination of education and relevant laboratory experience.
- Relevant experience in Quality Control, clinical laboratory testing, diagnostic reagent testing, pharmaceutical/biotechnology testing, or a related regulated laboratory environment.
- Hands-on experience operating and troubleshooting laboratory instrumentation.
- Demonstrated ability to interpret scientific data and identify unexpected or atypical results.
- Strong documentation skills and attention to detail.
- Ability to manage multiple priorities and coordinate testing activities in a deadline-driven environment.
- Strong written and verbal communication skills.
- Demonstrated ability to work effectively both independently and collaboratively within a cross-functional team.
Preferred Qualifications
- Experience with Clinical Chemistry and/or Immunoassay analyzers and reagent systems.
- Experience performing in-process, finished-product/release, and stability testing.
- Experience participating in or leading OOS, atypical-result, or laboratory investigations.
- Experience troubleshooting assay and instrument performance issues.
- Experience working within a regulated IVD, medical device, pharmaceutical, biotechnology, or similar Quality System environment.
- Experience writing or revising SOPs, test methods, or other controlled documentation.
- Previous experience training or mentoring laboratory personnel.
- Demonstrated experience coordinating laboratory workload, testing priorities, or product-release activities.
Skills
- Technical and scientific problem solving
- Investigation leadership
- Clinical Chemistry and Immunoassay testing expertise
- Instrument and assay troubleshooting
- Quality and compliance mindset
- Data analysis and interpretation
- Planning and prioritization
- Technical leadership and mentoring
- Cross-functional collaboration
- Clear written and verbal communication
- Attention to detail and data integrity
- Continuous improvement
Schedule
First Shift (Days)
Environmental Conditions: Laboratory Setting
Pay
The hourly pay range estimated for this position based in Virginia is $23.26–$34.88. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.
Benefits
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs.
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
- Retirement and savings programs, such as a competitive 401(k) U.S. retirement savings plan.
- Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount.