Laboratory Lead Quality Assurance Officer

Job Title: Laboratory Lead Quality Assurance Officer

Reports To: Laboratory Manager/Quality Manager

Date: March 18, 2025

Job Summary:

Responsible for activities involving quality assurance and compliance with regulatory requirements. Monitor the laboratory quality system to ensure quality throughout all laboratory processes.

Essential Duties and Responsibilities:

· Focused on implementing the Lab Managers decisions through the work of laboratory staff. Oversee day to day activities in the lab, including accessioning, order entry, data analysis, quality review and data reporting.

· Ensure test results are timely and accurately transmitted/delivered to laboratory manager

· Notify clients of samples releases, delays, and routine failures

· Prioritize work, manage workflow, and coordinate employee efforts

· Responsible for ensuring laboratory staff is trained; including cross training

· Performs laboratory testing, as needed

· ISO 17025 Compliance:

· Ensure the laboratory operates in full compliance with ISO 17025:2017 accreditation standards. This includes maintaining the quality management system, conducting regular reviews, and ensuring ongoing compliance with standards’ requirements for competency, impartiality, and consistency in testing.

· Regulatory Compliance:

· Ensure testing activities meet all applicable New York State Office of Cannabis Management (OCM) regulations, including staying updated on changes to OCM regulations and ensure that the lab adapts accordingly.

· Audit and Inspection:

· Lead and participate in internal and external audits, including assessments by accrediting bodies, clients, and regulatory agencies.

· Act as the main point of contact during audits, preparing documentation and corrective action plans as needed.

· Corrective and Preventive Actions (CAPA):

· Investigate non-conformances, deviations, and quality control issues. Implement corrective and preventive actions to address identified issues.

· Ensure all corrective actions are documented and followed through effectively.

· Documentation and Recordkeeping:

· Ensure accurate and complete documentation of all testing processes, calibration records, instrument maintenance logs, quality control results, corrective actions, and audit findings.

· Maintain organized and up-to-date records in compliance with ISO 17025 and regulatory requirements

· Training and Development:

· Develop and implement training programs for laboratory staff on quality systems, laboratory procedures, and OCM regulations.

· Ensure all personnel are trained on the proper use of equipment, quality standards, and industry best practices.

· Quality Control Monitoring:

· Oversee the quality control activities in the laboratory, including data investigations, proficiency testing, equipment calibration, and method validation.

· Monitor the performance of laboratory instruments, ensuring they are properly maintained and calibrated to meet ISO standards.

· Establish and maintain productive working relationships with people inside the laboratory and people outside the laboratory including customers, regulatory staff and corporate staff

Supervisory Responsibilities:

Carry out leadership responsibilities in accordance with the organization’s policies and applicable laws; responsibilities include: interviewing, hiring and training, onboarding, staffing/workplace planning, assigning and directing work, scheduling, evaluating performance, recognizing and rewarding, disciplining, addressing complaints and resolving problems, serving as technical resource for laboratory staff, ensuring laboratory equipment is properly calibrated and maintained, ensuring unbiased and positive treatment of all staff, opening and following-up with LIMS tickets.

Additional Responsibilities:

· Participate in state, other audits

· Participate in data integrity investigations, as assigned by the Quality Manager or Laboratory Manager

· Participates in technical discussions both internally and with clients

· Complete special projects associated method enhancements, statistical/trend analysis

· Perform other duties as may be assigned

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience:

· Bachelor’s degree in Chemistry, Microbiology or related science

· Minimum of 2 year of experience working in a GLP or ISO 17025 accredited laboratory preferred

Knowledge, Skills and Abilities Required:

· Knowledge of elementary principles of microbiology and chemistry

· Knowledge of basic statistics used in data analysis

· Ability to perform root-cause and trends analyses

· Ability to use computers and computer software programs and systems and standard office equipment such as phones, photocopiers and fax machines

· Good written and verbal communication skills to convey and receive information effectively (face-to-face, telephone and electronic)

· Good analytical and judgment skills

· Detail-oriented

· Excellent organizational skills to work independently, prioritize, handle multiple tasks, manage time

Certifications, Licenses, Registrations:

None

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

· Prolonged periods of sitting at a desk and working on a computer, walking/moving around and standing, talking and hearing and using hands to handle, control or feel objects, tools or controls

· Occasional periods of stooping/kneeling, bending

· Close vision and ability to focus on computer screens and documents; distance vision; peripheral vison; depth perception; color vision

Mental Requirements:

The mental demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

· The ability to learn new tasks, remember processes, and maintain focus.

· Complete tasks independently, make timely decisions in the context of a workflow.

· The ability to communicate effectively with internal and external members of the operation.

· The ability to complete tasks in situations that have a speed or productivity quota.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The employee works in a laboratory environment.

While performing work-related duties the employee occasionally works with hazardous, toxic or caustic chemicals such as acids and solvents, works around fumes or airborne particles from laboratory chemicals used/fume hoods works with or near moving mechanical parts from laboratory equipment and works with equipment that vibrates. The noise level in the work environment is usually moderate.

Stressful Conditions in the Work Environment Affecting This Position:

· Challenging work demands including heavy workload/work quantity or quality demands, time demands, conflicting/multiple deadlines or tasks

Work Schedule:

· 40 hours a week

This job description is intended to describe the essential functions of and requirements for the successful performance of this position. It is not to be interpreted as an exhaustive statement of duties, responsibilities or requirements of this position, nor is it intended to limit the authority of any manager to assign and direct the activities of employees under his or her direction.

Job Type: Full-time

Pay: $25.00 - $30.00 per hour

Schedule:

• Monday to Friday

Ability to Commute:

• Halfmoon, NY 12065 (Required)

Ability to Relocate:

• Halfmoon, NY 12065: Relocate before starting work (Required)

Work Location: In person

Salary : $25 - $30