Laboratory Quality & Compliance Specialist

Laboratory Quality & Compliance Specialist

Location: Harrisburg, PA
Work Schedule: Monday-Friday, 8:00 AM - 4:30 PM (1-hour lunch)
Work Arrangement: Hybrid/Part-Time Telework Available
Pay Rate: $75 - 80.00 per hour

We are seeking an experienced Laboratory Quality Assurance Specialist to lead laboratory quality assurance, compliance oversight, and regulatory standards development within a highly regulated testing environment. This senior-level position will be responsible for establishing and maintaining laboratory oversight programs, ensuring testing integrity, developing quality standards, and supporting product safety initiatives.

The ideal candidate will possess advanced expertise in analytical chemistry, laboratory quality management systems, accreditation standards, statistical analysis, and regulated laboratory operations. This role requires a combination of scientific leadership, regulatory oversight, data analysis, and stakeholder engagement.

Key Responsibilities

Quality Assurance & Laboratory Oversight

• Develop, review, revise, and implement quality assurance programs for certified laboratories.
• Establish policies and procedures governing analytical testing, chain of custody, reporting practices, and laboratory instrumentation maintenance.
• Conduct laboratory audits and inspections to evaluate compliance with quality standards, accreditation requirements, and regulatory expectations.
• Review findings, document deficiencies, and evaluate corrective action plans.
• Develop and maintain quality review frameworks and oversight procedures.

Regulatory Compliance & Standards Development

• Develop and maintain laboratory policies, guidance documents, procedures, and technical standards.
• Draft, review, and implement regulations related to laboratory operations and testing practices.
• Ensure regulatory compliance and alignment with accreditation requirements.
• Evaluate new accreditation standards and recommend implementation strategies.
• Support policy development through scientific and technical expertise.

Data Analysis & Integrity Monitoring

• Analyze laboratory and product testing data to identify:
  • Statistical drift and systematic bias
  • Data manipulation or fraud
  • Abnormal testing or retesting patterns
  • Product consistency concerns
  • Batch anomalies and trend deviations
  • Translate analytical chemistry data into defensible regulatory and compliance conclusions.
  • Prepare investigative reports and recommend corrective actions based on findings.

Scientific Leadership

• Evaluate analytical testing methodologies and emerging technologies.
• Recommend improvements to testing standards, laboratory protocols, and regulatory frameworks.
• Monitor scientific literature, technological advancements, and industry trends.
• Conduct research and provide recommendations for future program enhancements.

Training & Stakeholder Support

• Develop training materials, educational resources, and instructional programs.
• Conduct presentations, workshops, and technical training sessions.
• Provide guidance to laboratories, industry stakeholders, and internal teams.
• Represent the organization at professional meetings, conferences, and stakeholder engagements.

Required Qualifications

Education

One of the following is preferred:

• PhD in Analytical Chemistry, Pharmaceutical Sciences, Toxicology, Biochemistry, or a closely related scientific discipline
• Master's degree in a related field with significant industry experience
• Equivalent combination of education and relevant professional experience

Experience

• 10+ years of experience in regulated laboratory environments.
• Senior-level analytical chemistry experience.
• Experience leading laboratory quality assurance and compliance initiatives.
• Experience conducting audits, inspections, and laboratory assessments.
• Proven experience developing and implementing quality management systems.

Technical Expertise

Strong experience with:

• Chromatography techniques (HPLC, GC-MS, LC-MS/MS, GC-FID, etc.)
• Method validation and verification
• Contaminant and product safety testing
• Statistical analysis and uncertainty assessments
• Proficiency testing and inter-laboratory comparison programs
• Data trending and integrity reviews
• Quality management systems
• ISO accreditation standards, including ISO/IEC 17025
• FDA and DEA regulated testing environments
• Laboratory regulatory compliance and oversight

Preferred Qualifications

• Forensic laboratory experience
• Pharmaceutical quality system experience
• Public health laboratory oversight experience
• Accreditation and quality auditing experience
• Regulatory affairs experience
• Advanced statistical analysis and data science capabilities
• Experience developing laboratory policies, procedures, and training programs

Work Environment

• Primary office location in Harrisburg, PA.
• Part-time telework available.
• Travel required as needed for laboratory visits, audits, meetings, and industry conferences.

Compensation

$75.00 - 80.00 per hour

Qualified candidates with significant laboratory quality assurance, analytical chemistry, accreditation, and regulatory oversight experience are encouraged to apply. This role is ideal for a seasoned scientific professional seeking a leadership position focused on laboratory integrity, quality systems, compliance, and product safety.

Please Contact: Katherine Skelton