QA Associate

Job Description

Job Description

OMIC USA, Inc., Oregon

Job Description

Position Title : Quality Assurance Associate

Department : Quality Assurance Unit

Position Number : JD-023

Reports To : Quality Assurance Manager

FLSA Status : Non-Exempt

Prepared Date : Position Start or Revision of Current Duties

OMIC USA, Inc. is an international Analytical Laboratory and is committed to global food health and safety through the analytical testing services we offer to our clients.

MISSION OF THE ROLE :

The Quality Assurance Associate position supports the Quality Assurance Manager in the tasks required to verify regulatory compliance of all operations associated with the laboratory (e.g. sample receipt, processing, analytical, reporting, sales and human resources, etc.) with accreditation standards. (e.g. ISO / IEC 17025 : 2017) and contributes to the on-going development of the laboratory’s quality management system. Based on experience, the Associate can take self-directed ownership for some QA tasks and contribute to quality management system continuous improvement. Serves as QA Manager’s backup as directed.

RESPONSIBILITIES : Other duties may be assigned.

• Support the Quality Assurance Manager in maintenance and continuous improvement of the quality management system.

This includes but is not limited to :

reference material / solution tracking, reagents & solutions tracking, equip verification logs, instrument logbooks, training records, document control, and data package compliance.

Coordinate external calibration and / or repair of equipment as needed. Communicate non-conformities to Quality Assurance Manager for course of action and / or data impact assessments.

The actual training tasks may be performed by this position or other assigned laboratory personnel, however this position is responsible for being a back-up trainer.

SUPERVISORY RESPONSIBILITIES :

This role has no supervisory responsibilities.

SKILLS AND EXPERIENCE :

EDUCATION

Bachelor's degree (B.S.) in Chemistry, Biology or related science from a four-year college or university and two years relevant QA experience working in a regulated laboratory; or equivalent combination of education and experience.

CERTIFICATES, LICENSES, REGISTRATIONS

None

SKILLS & EXPERIENCE

PERFORMANCE FACTORS

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LANGUAGE SKILLS

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write Standard Operating Procedures, analytical methods, reports, business correspondences, and additional laboratory documentation.

Ability to perform standard quality assurance / quality control evaluation procedures, including audits. Technical writing for preparing manuals and documentation.

MATHEMATICAL SKILLS

Ability to apply advanced mathematical concepts such as exponents, logarithms, and quadratic equations. Ability to apply mathematical operations to tasks such as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

SKILLS & EXPERIENCE

OTHERS :

TRAINING REQUIREMENTS

OJT in understanding company operating systems, including the maintenance and operation of extraction and analytical equipment, and passing the Initial Demonstration of Capability (IDOC) for existing SOPs.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is regularly required to be able to hear and understand instructions and handle items involving repetitive hand and wrist movement. 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.

WORK ENVIRONMENT

Works in a laboratory using analytical equipment. Employee may have exposure to hazardous chemicals and solvents. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Management reserves the right to add, modify, change, or remove work assignments. This job description is designed to outline primary duties, qualifications, and job scope, but not limit the employee nor the company to just the work identified. It is OMIC USA Inc.’s expectation that each employee will offer their services wherever and whenever necessary to ensure the success of the Company and that each employee is adhering to the Company’s policy set up in the Company’s Employee Handbook.