Senior Quality Assurance Specialist

3 weeks ago

Horsham, Pennsylvania, United States NMS Labs Full time

Title: Quality Assurance Compliance Specialist

Department: Quality Assurance

Job Type: Regular Full Time

Location: Horsham, PA/Hybrid – at least 3 days in the office

Shift: Monday through Friday – 1st

Company Summary:

NMS Labs has developed an extensive menu of more than 2,500 Clinical and Forensic toxicology tests to support clients in healthcare, public health, and public safety 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 the diverse markets we serve, 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 Summary:

Under limited supervision, the Quality Assurance Compliance Technical Specialist will assist in monitoring regulated work conducted at NMS Labs for compliance with study protocols, internal processes, procedures, company contracts, company quality standards, and company-controlled documents. This Quality Assurance Compliance Specialist will report directly to the Quality Assurance Compliance Supervisor and will be completely independent of any laboratory operations.

Requirements:

  • Bachelor's degree in a chemical, physical or biological science with a minimum of 3+ years diverse laboratory experience
  • Or
  • Master's degree in chemistry, physical or biological science with 1-year diverse laboratory experience
  • 3 years' experience in QA auditing involvement.

Preferred:

  • Experience with leading a project.

Major Duties and Responsibilities:

  • Participate in activities designed to assure regulatory compliance with licensing/accrediting agencies such as personnel licenses (tracking and submission to agency), external proficiencies (tracking, data submission, data entry for grading), and/or document control within the compliance software.
  • Perform scheduled internal audits at a frequency to assure compliance with applicable processes and procedures.
    • Observe work practices and report any deviations from protocol, method, SOP, or regulations. Notify Supervisor and appropriate personnel of the audit findings by documenting the scope of audit and findings in a written report.
    • Perform follow-up audits as necessary to verify that appropriate corrective action has been completed.
      • Participates in Continuous Quality Improvement efforts.
      • Approved to be a lead auditor in the NMS Labs Internal Audit Program. Writes reports of audit findings and makes recommendations to technical staff on corrective actions for findings.
      • Participate in updates to the audit matrix and/or design and scheduling of internal audits.
      • Reviews proficiency data prior to submission.
      • Reviews and grades proficiency survey results and issues reports for management review.
      • Assist project managers and testing supervisors (as needed) in setup and continuation of laboratory procedures in compliance with established laboratory processes and procedures.
      • Attend professional meetings and/or conferences on QA activities and relay information gained to the QA group.
      • Remains current in compliance trends for those areas of responsibility.
      • Participates/presents in laboratory continuing education program as needed.
      • Ensure that pertinent information is entered into and maintained in the appropriate QA files.
      • Assists QA Regulatory with external audits/inspections, as applicable.
      • Other duties as assigned.

Knowledge, Skills, and Abilities:

  • Ability to define and resolve problems, collect data, establish facts, and draw valid conclusions.
  • Ability to read and audit complex technical data and procedures to determine compliance with established processes and procedures.
  • Ability to make effective and persuasive speeches and presentations to peers and management for the purpose of effecting changes necessary for regulatory compliance.
  • Ability to identify operationally efficient strategies to adhere to quality compliance requirements.
  • Ability to effectively present information and respond to questions from all co-workers.
  • Ability to effectively prioritize assignments to meet long and short-term deadlines.
  • Strong organization, documentation skills, attention to detail, and able to prioritize assignments to meet deadlines.
  • Possess good computer skills (to include Excel and Word) and internet usage.
  • Ability to travel, including out of state.
  • Maintains regular and reliable attendance.

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 and 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, sex, 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), domestic violence victim status, arrest record, or predisposing genetic characteristics.

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