Quality Associate

ACT Laboratories

Job Title: Quality Assurance Associate

Reports To: Director of Quality

Date: April 20, 2024

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:

• Monitor quality standards compared with established targets
• Halt laboratory processes out of control or for non-conforming events; report immediately to Quality Director
• Participate in the lab’s quarterly audits based on ISO 17025 policies; work as a member of a team to ensure deficiencies are corrected in compliance with all policies
• Perform batch reviews and upload documents into Amazon WorkDocs for client sample results
• Review laboratory activity logs/forms conducted during the week that are not part of the weekly batch
• Perform monthly reviews of the Master Equipment List to verify all equipment is calibrated
• Perform spot checks of preventative maintenance to confirm completion at the appropriate time
• Review Quality and Results Sheets to confirm all system suitability checks have passed prior to reporting client data
• Conduct annual reviews of training
• Conduct annual reviews of Standard Operating Procedures, including updates or new documents
• Review, approve and track Corrective and Preventative Actions
• Review Out of Specification/atypical lab result investigations
• Review and approve site change controls
• Perform annual evaluations of approved vendors to ensure the quality and performance of the vendor is satisfactory. This evaluation includes quality performance, on time delivery, pricing, and responsiveness/cooperation in addressing the lab’s needs
• Define possible risks on quarterly basis
• Compile and perform data integrity and ethics training for all lab staff annually
• Author and/or review proposed Standard Operating Procedures and develop gap assessments of Standard Operating Procedures
• Perform monthly/quarterly reviews of laboratory operations including metrics, Corrective and Preventative Actions, retests, customer complaints, CCV failures
• Complete weekly laboratory walk-through to ensure day-to-day operations follow ISO 17025 policies
• Generate quarterly reports summarizing Quality Assurance / Quality Control activities (including proficiency tests, change control processes, lab investigations), areas or ideas for improvement and Quality Control trends
• 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:

None

Additional Responsibilities:

• Participate in state, other audits
• Participate in data integrity investigations, as assigned by the Quality Director
• 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 1 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

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, Monday through Friday

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: $20.00 - $25.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 1 year

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Education:

• Bachelor's (Required)

Experience:

• Laboratory: 2 years (Preferred)
• Cannabis: 1 year (Preferred)
• ISO 17025: 1 year (Required)
• Quality assurance: 1 year (Required)

Ability to Relocate:

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

Work Location: In person

Salary : $20 - $25