Quality Associate

The Position

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

Pay: 20-22.50

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.

Requirements

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 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

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

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

Equal Opportunities

ACT Laboratories provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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