Quality Assurance Specialist I

Position Summary

The Quality Assurance (QA) Specialist I is responsible for supporting and advancing the laboratory’s quality management system through the application of specialized knowledge in laboratory practices, regulatory standards, and quality control procedures. This role evaluates quality data, investigates complex quality issues across all phases of the testing process (pre-analytic, analytic, and post-analytic), and determines appropriate corrective and preventive actions (CAPAs) to mitigate risk and ensure compliance.

The QA Specialist I independently analyzes quality metrics and trends, develops reports, and provides recommendations that inform operational and business decisions. This role advises and influences cross-functional stakeholders and provides authoritative guidance on quality and compliance matters. Through these efforts, the QA Specialist I directly impacts laboratory accreditation and regulatory standing while helping to reduce organizational risk exposure.

The QA Specialist I leads and contributes to cross-functional initiatives to resolve systemic quality issues and drive continuous improvement. This role authors and maintains standard operating procedures (SOPs), policies, and controlled documentation to ensure alignment with regulatory requirements, including HIPAA, CLIA, CAP, CLEP, OSHA, ISO, FDA, and other applicable standards.

Operating with minimal supervision, the QA Specialist I prioritizes and manages workload based on business needs and risk, serving as a key resource to leadership on quality and regulatory matters. This role supports leadership decision-making on compliance strategy and operational performance while fostering a culture of quality and continuous improvement across the organization.

What you’ll be doing:

• Investigate quality incidents and prepare documentation, including incident reports, deviations, and corrective and preventative action (CAPA) plans.
• Evaluates and resolves complex quality issues impacting compliance and operations.
• Collects and independently analyzes QA data and presents to leadership.
• Conducts quality metric reviews and corresponding reports related to laboratory quality, including independent evaluation of appropriate corrective actions and advising key stakeholders of corrective action plans.
• Oversees and evaluates laboratory quality control experiments and processes, as needed, and authors corresponding reports.
• Effectively monitors and analyzes key quality metrics, to include report design, graphical display, and analytical interpretation.
• Leads cross-functional collaboration to ensure timely review and approval of materials.
• Leads desk audits to evaluate ongoing compliance of laboratory accreditation requirements, including CLIA, CAP, and CLEP and advises key stakeholders on recommendations or improvements.
• Prepares, reviews, and ensures timely submission of documents to regulatory agencies.
• Participate in both internal and external quality audits.
• Reviews and updates policies and procedures related to quality assurance, including continuous improvement of processes.
• Manages completion of the Alternate Proficiency Assessment (APA) or other Proficiency Testing (PT) as appropriate and authors corresponding reports for Medical Director review and approval.
• Reviews laboratory quality plans and evaluates trends and metrics to maximize performance improvement and error reduction processes. Advises key stakeholders of and leads implementation of quality plans as appropriate.
• Leads quality initiatives including designing and implementing quality improvement plans.
• Synthesizes and presents QA data to inform leadership decision-making.
• Has strong knowledge of HIPAA requirements.
• Audits and enforces compliance with equipment maintenance activities and maintenance records.
• Creates and administers quality training, such as good documentation practices, good lab practices, and quality auditing practices.
• Develop, review, and interpret policies and procedures, providing quality-focused feedback.
• Performs other duties as assigned.

What you’ll need:

• Minimum of 2 years of full-time experience in a CAP or CLIA regulated environment.
• • Experience with CLEP, ISO, and FDA regulations is preferred.
• Strong knowledge of clinical laboratory processes, equipment, and quality control practices.
• Successfully managed quality control improvement or routine quality performance report.
• Experience conducting laboratory QC experiments (e.g., lot-to-lot testing).
• Understanding of aseptic techniques and safe handling of chemicals and biological materials.
• Familiarity with good documentation practices in a cGxP-regulated environment.
• Knowledge of clinical laboratory safety, including bloodborne pathogen precautions.
• Strong interpersonal skills and ability to collaborate across diverse teams.
• Demonstrates a proactive attitude toward receiving feedback and actively engages in ongoing professional development activities.
• Excellent written, verbal, and presentation skills, with the ability to explain technical concepts clearly.
• Excellent attention to detail and auditing capability.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Experience working within Laboratory Information Management Systems (LIMS).
• Experience with Electronic Quality Management Systems (eQMS) and Electronic Document Management Systems (EDMS) platforms preferred.
• Experience delivering training on laboratory and quality topics.
• Experience handling Protected Health Information (PHI) in compliance with HIPAA.

Education, Certifications, and Licensures

• Bachelor’s degree in applicable science required.

Other

• Visual acuity and analytical skills to distinguish sufficient detail.
• Manual dexterity to use standard laboratory equipment and perform sterile techniques as required.
• Must possess the ability to sit or stand for long periods.
• Must possess the ability to perform repetitive motion.
• Ability to lift up to 25 pounds.
• Potential exposure to biohazardous materials and laboratory chemicals, including xylene (a known carcinogen), paraformaldehyde (a suspected carcinogen), and alcohol fumes. Possible interaction with sharps and biological specimens, including materials that may contain bloodborne pathogens. Hepatitis B vaccination is recommended and offered by the employer.

Grow Your Career With Us

CND Life Sciences is a patient and employee-centric, future-focused organization. We know there is a patient hoping for answers behind every Syn-One test we perform, and this knowledge drives us day in and day out to be our best. We are dedicated, driven, and passionate with a strong sense of community and team spirit.

CND offers plenty of advancement opportunities and excellent benefits to include medical, dental and vision, STD, LTD, Life, AD&D, and 401K with an employer match and encourages a positive work life balance.

Our Mission

Since our founding, CND Life Sciences has been on a mission to advance the care of patients who face the potential diagnosis of a neurodegenerative disease. With long careers in research and clinical care, our founders set out to unlock deeper stories within the skin by detecting key pathological markers in the peripheral nervous system that had been previously out of reach.

Our Core Values

CND maintains core values that guide our work and mission every day.

Great science. It’s the foundation of everything we do.

Patients first. There is a patient hoping for answers behind every test we perform – we never forget that.

Clinician-minded. We are founded by physicians and dedicated to helping clinicians care for patients – we embrace this responsibility.

Quality core. We adhere to high laboratory standards and quality practices – it’s the only way to operate.

Always thinking. We are relentless in determining how we can innovate and do better – it’s just in our DNA.

Respect. We hold our employees, customers, partners, and suppliers in high regard – we succeed when we are aligned.

CND Life Sciences is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status.