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Microbac Laboratories, Inc. · 1 day ago

Quality Assurance Specialist

Turlock, CA, US

Full-time

Onsite

Entry, Mid Level

$22.40/hr - $27/hr

2+ years exp

Microbac Laboratories, Inc. is a premier commercial laboratory testing firm that partners with clients worldwide. The Quality Assurance Specialist oversees the development, implementation, and maintenance of quality systems throughout accredited commercial laboratories, ensuring compliance with regulatory and company standards.

BiotechnologyEnvironmental Consulting

Responsibilities

Ensures that the management system is established, implemented, and maintained in accordance with the applicable standards in their laboratory and by the use of Microbac’s Intellect QMS system

Serves as the focal point for QA/QC; has a general knowledge of the analytical methods for which data review is performed, documented training and/or experience in QA/QC procedures and is responsible for the oversight and/or review of quality control data

Functions independently from laboratory operations for which they have oversight being able to evaluate data objectively and perform assessments without outside influence

Maintains a master list of current versions of local quality documentation; handles the distribution locally maintained documents

Trains personnel on the management system

Monitors the corrective action process

Notifies laboratory management of deficiencies in the quality system

Oversees the laboratory’s proficiency testing program

Coordinates laboratory accreditation activities

Leads, plans, organizes, and supports the activities and resources related to implementing and maintaining effective quality systems throughout the laboratory including but not limited to document control, CAPA, internal audits, control charts & trend analysis, in-depth data monitoring, approved suppliers and validation of methods, systems & instrumentation

Responsible for continual improvement of the management system through use of control charts and other method performance indicators; e.g., PT samples, internal and external audits

Writes, reviews and revises SOPs and technical reports

Ensures the laboratory is fully compliant with all relevant regulatory standards

Prepares monthly reports both to local divisional management and to the corporate quality team summarizing quality activities at the laboratory

Serves as the laboratory contact for the Ethics and Data Integrity Program

Hosts and responds to client audits, leads the process to ensure observations are addressed

Qualification

ISO17025 knowledgeQuality Management SystemAccreditation processesAnalytical test methodsMicrosoft Office SuiteLeadership abilityCommunication skillsCross-functional teamwork

Required

Bachelor's degree from a four-year accredited institution in a related field and two years of related experience or 5 years work experience in lieu of a degree

Knowledge of applicable management system standards ISO17025, TNI (NELAC) and preferably CA ELAP Regulations

Knowledge of accreditation and/or certification processes

Desired field of degree: Quality Assurance, Regulatory Affairs, Chemistry, Biology or a closely related field

General knowledge of analytical test methods for which data review is performed

General knowledge of applicable quality systems and accreditation, licensing and/or certification requirements

Demonstrated leadership ability

Ability to effectively prioritize work and manage time to meet deadlines and rush orders

Excellent communication skills

Ability to work effectively with cross-functional teams

Use of both paper and electronic documents and files, chromatography data systems, or other instrumentation software

Ability to work in Quality Management System software system and Microsoft Office Suite