Quality Assurance Specialist

Quality Assurance Specialist Diagnostic Solutions Laboratory - 1.0 Alpharetta, GA Job Details Full-time $65,000 - $70,000 a year 1 day ago Benefits Health insurance Dental insurance 401(k) Paid time off On-the-job training Vision insurance 401(k) matching Life insurance Qualifications Biology Technical documentation Laboratory information management systems Laboratory staff training Six Sigma Bachelor's degree Laboratory regulatory affairs Staff training Laboratory quality control Implementation of OSHA safety standards

QA/QC CLIA

regulations Data interpretation Technical writing Training & development Root cause analysis Full Job Description QA/QC Specialist Job Summary The QA/QC Specialist is responsible for advancing and safeguarding the integrity of the organization's Quality Control program through strategic oversight of processes, documentation, and compliance systems. This role drives program-level quality initiatives, ensuring cross-functional alignment, and proactively identifying risks to regulatory compliance and operational performance. The Specialist oversees QC documentation systems, reagent and lot verification programs, targeted audit execution, method verification activities, and analyte tracking processes. This role ensures that all quality activities meet or exceed CLIA, CAP, OSHA, and internal standards while maintaining audit readiness at all times. In addition to technical oversight, the QA/QC Specialist facilitates KPI reporting, supports continuous improvement initiatives, and contributes to the development and enforcement of the organization's Safety Program. Acting as a subject matter expert, this role partners closely with leadership to strengthen quality systems, improve process reliability, and enhance overall laboratory compliance and performance. Job Duties Responsibilities include, but are not limited to:

• Provide program-level oversight of QA/QC systems to ensure sustained compliance with CLIA, CAP, OSHA, and internal standards.
• Oversee and continuously improve QC documentation practices, ensuring accuracy, completeness, and audit readiness.
• Lead reagent and lot-to-lot verification programs, ensuring traceability, consistency, and regulatory compliance.
• Design and execute targeted internal audits to assess process adherence, identify gaps, and mitigate compliance risks.
• Oversee method verification and validation activities to ensure analytical accuracy, reproducibility, and regulatory alignment.
• Perform and manage analyte tracking to monitor performance trends, detect deviations, and support quality decision-making.
• Facilitate and analyze KPI reporting related to quality metrics, identifying trends and driving data-informed improvements.
• Support and enhance the laboratory Safety Program by ensuring alignment with OSHA standards and internal safety protocols.
• Act as a subject matter expert for QC processes, providing guidance and support across departments.
• Partner with QA/QC leadership to develop and implement quality strategies, policies, and continuous improvement initiatives.
• Identify systemic quality risks and lead proactive solutions to prevent nonconformances.
• Support audit readiness by ensuring documentation, processes, and personnel are aligned with inspection expectations.
• Contribute to training development and provide technical support to QA/QC staff and cross-functional teams.
• Collaborate with cross-functional stakeholders to ensure quality is embedded in all operational workflows. Minimum Education and Qualifications Required Bachelor's degree in a biological science, chemistry, or related field.
• Minimum of 5-7 years of QA/QC experience in a regulated laboratory environment.
• Strong working knowledge of CLIA, CAP, OSHA, and applicable regulatory standards.
• Demonstrated experience overseeing quality systems, audits, or compliance programs.
• Strong analytical skills with the ability to interpret quality data and trends.
• Excellent documentation, technical writing, and communication skills.

Training Support:

Experience leading on the job training for QA/QC procedures and workflow.

• Proficient in QC interpretation, documentation, and root cause analysis Preferred Experience leading QC program initiatives or process improvement projects.
• Advanced training or certification in Quality Management, Lean, or Six Sigma.
• Experience with KPI development, reporting, and data-driven decision-making.
• Proven ability to drive cross-functional quality improvements.
• Experience supporting safety programs or regulatory inspections.

Why Join DSL? Diagnostic Solutions Laboratory is committed to advancing clinical testing that improves patient care. Joining our team means supporting meaningful scientific work while growing your leadership impact in a rapidly expanding laboratory environment. DSL is an equal opportunity employer and strongly encourages applications from people of color, persons with disabilities, women, and LGBTQ+ applicants.

Job Type:

Full-time Pay:

$65,000.00 - $70,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance

Education:

Bachelor's (Required)

Experience:

Laboratory information management systems: 1 year (Preferred)

QA:

1 year (Required) Ability to

Relocate:

Alpharetta, GA 30005: Relocate before starting work (Required)

Work Location:

In person