Laboratory Quality Assurance Expert

A-Line Staffing Solutions; Harrisburg (Dauphin County); Remote; USD 91,000 - 129,000; Part time

Benefits offered by this job

Benefits after 90 days

401(k) after 1 year

Job summary

We are seeking an experienced Laboratory Quality Assurance Expert to lead QA across laboratories testing medical cannabis. You will establish and maintain a comprehensive oversight program focused on quality, testing standards, inter-lab integrity, and regulatory compliance.

The role requires expert knowledge of analytical chemistry, quality systems, accreditation standards, and regulatory requirements. Responsibilities include audits, policy development, and actionable corrective actions to

Qualifications

• Extensive experience in analytical chemistry and QA.
• Knowledge of regulatory compliance and accreditation.
• Experience with laboratory audits and regulatory reviews.
• Strong technical writing, reporting, and documentation skills.
• Ability to translate complex analytical data into regulatory conclusions.

Responsibilities

• Develop and implement QA programs for laboratories testing medical cannabis.
• Establish policies for testing, chain of custody, and instrumentation maintenance.
• Audit laboratories for compliance with accreditation standards.
• Prepare reports and corrective action plans; manage QA actions.
• Represent the department with partners and at conferences.

Skills

Analytical chemistry

Quality assurance

Regulatory compliance

Statistical analysis

Lab leadership

Education

PhD or Master in Analytical Chemistry/related field

Job description

178181 MM Laboratory Quality Assurance Expert

Location: Harrisburg, PA 17120

Pay Rate: $80.00 per hour

Schedule: Monday–Friday, 8:00 AM–4:30 PM, with a one-hour lunch.

Work Arrangement: Part-time telework is available.

Travel Requirements: Travel as needed to visit laboratories, medical marijuana organizations, and attend conferences or other official functions.

Position Overview

We are seeking an experienced Laboratory Quality Assurance Expert with an extensive background in analytical chemistry, laboratory oversight, statistical analysis, and regulatory compliance. This position will provide technical leadership and oversight of laboratories certified to test medical marijuana, ensuring the quality, consistency, integrity, and safety of products intended for patients. The successful candidate will establish and maintain a comprehensive laboratory oversight program focused on quality assurance, testing standards, inter-laboratory integrity monitoring, and fraud and manipulation detection. This is an advanced professional-level opportunity requiring expert knowledge of laboratory testing methodologies, analytical chemistry, quality systems, accreditation standards, and regulatory requirements. The individual will translate complex analytical chemistry data into defensible regulatory conclusions, develop laboratory policies and procedures, conduct quality assurance audits, and recommend corrective actions to maintain compliance and protect patient safety.

Key Responsibilities

Develop, review, revise, and implement quality assurance programs for laboratories certified to test medical marijuana. Establish policies and procedures governing examination techniques, analytical reports, chain of custody, and laboratory instrumentation maintenance. Develop departmental guidelines, manuals, policies, and procedures to ensure certified laboratories comply with applicable federal and state laws and regulations. Develop and implement policies and procedures for laboratory testing, regulatory compliance, and product approval. Provide regulatory oversight of registered independent testing laboratories and ensure continued good standing with accreditation bodies. Continuously evaluate and improve laboratory services and operational business processes. Draft, review, and enforce departmental regulations and policies governing certified medical marijuana laboratory testing and results. Develop a quality review structure to ensure effective and efficient oversight of certified laboratories. Conduct quality assurance audits by visiting certified laboratories, inspecting laboratory operations, and reviewing completed test results for compliance with departmental policies and accreditation requirements. Document audit findings and deficiencies, recommend corrective actions, and review laboratory corrective action plans. Testify in legal proceedings when necessary regarding laboratory findings, quality assurance, and compliance matters. Develop standard operating procedures for laboratory quality reviews, deficiency documentation, and corrective action plan evaluations. Develop and administer a laboratory-wide safety program, including inspections and identification and resolution of safety concerns. Translate raw analytical chemistry data into regulatory conclusions that can withstand legal challenge. Analyze product data to identify potential fraud, manipulation, and irregularities. Prepare detailed reports documenting suspected product fraud and manipulation and recommend appropriate actions. Identify statistical drift and systematic bias in laboratory product data. Flag unusually consistent testing patterns that may indicate potential data manipulation. Identify THC inflation patterns, selective failing and retesting behavior, abnormal batch resubmission patterns, and inconsistencies between harvest and final product profiles. Prepare comprehensive reports documenting laboratory quality assurance programs and compliance with departmental policies and accreditation standards. Research medical marijuana product development and recommend legislative changes, inspection methods, and laboratory protocols to improve patient safety. Evaluate analytical techniques used within the medical marijuana industry and recommend whether they should be incorporated into laws, regulations, or departmental policies. Collaborate with department leadership to analyze proposed legislation and regulatory changes and provide recommendations. Develop and revise instructional methods, training materials, and techniques for standardized review of laboratory test results. Monitor scientific and technological advancements and industry trends to support ongoing program development. Evaluate new medical marijuana accreditation standards and determine appropriate methods for ensuring laboratory system compliance. Monitor and analyze scientific and laboratory literature, industry developments, and emerging cannabis products to inform regulatory recommendations. Develop and deliver training to department staff, medical marijuana organizations, and certified laboratories regarding departmental policies, procedures, and practices. Demonstrate analytical techniques and provide practical training exercises. Participate in professional laboratory work as needed to maintain technical proficiency and meet operational requirements. Represent the department when working with local and state government partners, registered laboratories, research institutions, educational organizations, and the public. Represent the department at conferences, meetings, presentations, and other official functions.

Required Qualifications

Extensive professional experience in analytical chemistry, laboratory quality assurance, laboratory oversight, or a related scientific discipline. Expert-level knowledge of laboratory testing methodologies and analytical chemistry. Strong experience working in regulated laboratory environments, preferably pharmaceutical, cannabis, medical marijuana, or public health testing systems. Extensive knowledge of chromatography and analytical testing methodologies. Experience with contaminant testing and product safety evaluation. Expertise in laboratory method validation and uncertainty analysis. Experience with inter-laboratory comparison studies and proficiency testing design. Strong understanding of statistical analysis, data science, and analytical data interpretation. Experience identifying statistical drift, systematic bias, data inconsistencies, and potential testing manipulation. Knowledge of laboratory quality assurance programs, accreditation requirements, and regulatory compliance. Familiarity with ISO accreditation systems and standards. Familiarity with FDA- and DEA-regulated testing environments. Knowledge of state public health laboratory oversight and regulatory systems. Ability to develop laboratory policies, procedures, guidelines, and standard operating procedures. Experience conducting laboratory inspections, quality assurance audits, and compliance reviews. Ability to identify deficiencies, recommend corrective actions, and evaluate corrective action plans. Strong technical writing, reporting, and documentation skills. Ability to interpret complex analytical chemistry data and develop defensible regulatory conclusions. Strong research, analytical, and problem-solving skills. Ability to communicate complex scientific information to technical and nontechnical audiences. Ability to provide technical guidance, training, and leadership to laboratory professionals and other stakeholders.

Preferred Education and Experience

PhD or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, Toxicology, Biochemistry, or a closely related scientific discipline. Equivalent industry experience may be considered in place of an advanced degree. Approximately 10 or more years of experience in regulated testing environments. Extensive experience overseeing laboratory operations, quality assurance programs, and regulatory compliance. Experience in pharmaceutical, cannabis, medical marijuana, or public health laboratory systems. Experience developing and implementing laboratory testing standards, quality assurance programs, and accreditation procedures.

Benefits

• Benefits are available to full-time employees after 90 days of employment.
• A 401(k) with company match is available after 1 year of service.