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QA Associate

hace 24 días

Portland

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. • Perform in-depth Internal Audits, • Continuous improvement, and implementation of systems for compliance, • Proactive document control to ensure all documents are within the system, • Proficiency Testing; scheduling, reporting & follow up, • Supplier qualification, and traceability, • Perform internal audits of the quality management system to ensure compliance to the appropriate standards and accreditation programs and identify areas of non-conformance and/or areas for improvement., • Perform procedural audits of methods conducted in the laboratory against the appropriate SOPs and LABs to ensure accuracy of procedural documentation and adherence to laboratory procedures in the areas of analytical technique, QC and quality system compliance, including:, • reference material/solution tracking, reagents & solutions tracking, equip verification logs, instrument logbooks, training records, document control, and data package compliance., • Report audit details (observations, findings, non-compliances and non-conformances) to the Quality Assurance Manager and assist with resolution as applicable., • Supports the Quality Assurance Manager and assists in external audit activities as needed, including implementation of corrective action and improvements the Laboratory receives, as they relate to the quality management system., • Promote QAU information and QA training to laboratory staff, in meetings and as needed., • Periodically reconcile database records of Suppliers of externally provided products and services to the laboratory, to ensure qualification records are kept up to date; maintain supporting documentation and traceability in LIMS., • Records new laboratory equipment information in LIMS for unique identification and tracking purposes. Work with laboratory staff to ensure routine maintenance documentation is in place before use., • Coordinate and oversee internal & external calibration and verification of laboratory support equipment (pipette performance, temperature accuracy, etc.) The actual calibration/verification tasks may be performed by this position or other assigned laboratory personnel, • 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., • Maintain documentation of support equipment calibration both internal and external (hard copy, electronic and data base)., • Ensure training of new lab personnel on operation and best practices for pipette use and handling, when applicable., • 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., • Assists the Quality Assurance Manager and laboratory staff by reviewing new or revised documentation for overall conformity with our internal policies and procedures as well as regulatory compliance, when applicable, prior to inclusion in the Document Control systems., • Ensure that routine maintenance/consumable replacement for residue water purification systems and on-site technician visits are scheduled as needed. Audit electronic water quality/use logs and records to ensure they are being maintained as needed. Ensure new personnel are trained in operation and best practices; serve as back-up trainer., • Periodically reconcile database records of reference materials and solutions to ensure that records are complete and accurate; maintain documentation of notification for corrections to be made by Chemists and traceability of completion. Ensure disposal of expired solutions (and neat as applicable). Periodically check physical neat standards and stock solutions for compliance (correct labeling, assigned physical locations, etc.) and maintain records of non-compliance. 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 • Working knowledge of common laboratory equipment types, test methods, and regulations/ standards (preferably ISO 17025 or similar), • Improvement initiatives, • Learning initiatives, • Ability to handle multiple priorities and deadlines, • Analytical and problem-solving skills, • High emotional Intelligence, • Good cultural awareness and communication with people who have diverse backgrounds, • Experienced user of MS Office and Adobe Acrobat PERFORMANCE FACTORS Page Break • Quality of Work, • Communication, • Adaptability, • Teamwork, • Time Management, • Knowledge and Skills, • Initiative, • Dependability Page Break 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 • Familiar with the laboratory business environment 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.

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