Quality Assurance Specialist II

Title: Quality Assurance Specialist

Department: Quality Assurance

Job Type: Hybrid Full-Time

Location: Horsham, PA

Shift: 1st

Schedule: Monday through Friday 8:30 am to 5:00 pm

Summary:

NMS Labs has developed an extensive menu of more than 2,500 tests to support clients in forensic, criminalistic, public health and clinical fields. For over 50 years, our clients have relied on NMS Labs for unique testing solutions that demonstrate our company core values of Quality, Integrity, Service, Innovation and Engagement. As we work to increase the company's positive impact on public health and public safety, we are seeking talented professionals to join us for the journey! We invite you to learn more about our company by visiting NMSLabs.com.

Job Description:

We are seeking a Quality Assurance Specialist who will play an important role in ensuring compliance with regulatory, accreditation, contractual, and internal quality system requirements. This role operates independently from laboratory operations and partners closely with crossfunctional teams to support audit readiness, CAPA effectiveness, vendor oversight, and continuous quality improvement. Regular use of KPIs and quality data to support risk management and improvement initiatives is expected.

Major duties and responsibilities include:

• Maintain accurate quality records and documentation within QA systems.
• Perform internal audits to assess compliance with procedures, regulations, accreditation standards, and contracts.
• Support preparation and execution of external audits, inspections, and assessments.
• Document internal & external audit findings and communicate results to stakeholders.
• Remediate audit deficiencies through cross-functional collaboration with stakeholders.
• Lead and support quality investigations and CAPA activities, including review, approval, tracking, and effectiveness verification.
• Support vendor management activities, including vendor audits, evaluations, qualification, and ongoing performance monitoring.
• Participate in the evaluation and implementation of vendor and client contracts from a quality and compliance perspective.
• Support regulatory test notifications and reporting to state agencies.
• Develop, review, and maintain policies, procedures, and related training materials.
• Monitor KPIs, risks, and Opportunities for Improvement (OFIs) to support data-driven quality decisions.

Required Qualifications:

• Bachelor's degree in a chemical, physical, or biological science, or equivalent experience.
• Experience working in a regulated laboratory environment (laboratory, healthcare, manufacturing, or similar).
• Experience with deviation management and CAPA review/approval.
• Experience using S.M.A.R.T. goals and KPIs to drive quality or business decisions.
• Minimum of three years' employment in a diverse laboratory setting. Clinical and/or forensic laboratory experience is preferred. (A master's degree + one year laboratory employment is an acceptable substitute.)
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• Previous experience of 1-3 years with Quality Systems and laboratory regulations/accreditation is required.Experience must include direct QA auditing involvement and demonstrated experience participating in process improvement initiatives.

Preferred Qualifications:

• Experience supporting DEA and/or CDC-related compliance.
• Experience with vendor management programs.
• Knowledge of biosecurity, cybersecurity, and/or HIPAA compliance.
• Experience with regulatory analysis and quality or compliance strategy.
• Previous laboratory or quality assurance work experience to support clinical and/or forensic toxicology testing.

Skills:

• Ability to interpret and apply regulations, standards, and internal requirements.
• Strong analytical skills with the ability to identify gaps, trends, and improvement opportunities.
• Effective written and verbal communication skills, including audit reporting and stakeholder interactions.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities.
• Proficiency with standard business software (e.g., Word, Excel) and quality systems.
• Ability to work independently while collaborating effectively across teams.

Physical Demands:

• Ability to talk, hear, stand, reach with hands and arms, and use hands and fingers to manipulate computer keyboard, objects, tools, or controls.
• Specific vision abilities (with correction) include close and distance vision.
• Walking and carrying objects from one work location to another.
• Sitting and standing, sometimes for periods of time.

Offers of employment are made contingent upon a nationwide background investigation and urine drug screen with results satisfactory to standards of employment at NMS.

• We are an equal opportunity employer and will not discriminate against any employee or applicant for employment because of race, creed, sexual orientation, color, religion, gender, sex, sex identity, gender identity, national origin, age, marital status, citizenship status, otherwise qualified disability, or protected veteran status (disabled, Armed Forces Service Medal, recently separated, active duty or campaign badge).