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ArcherDX: Quality Assurance Specialist Ii/Iii

ArcherDX

This is a Full-time position in Boulder, CO posted September 19, 2020.

Position: Quality Assurance Specialist II/III (PCM) (ADX-195-20) Location: Boulder, COJob Id: 812 # of Openings: 2 Quality Assurance Specialist II/III (PCM) (ADX-195-20)p.P1 {margin: 0.0px 0.0px 0.0px 0.0px; font: 12.0px ‘Helvetica Neue’}p.P2 {margin: 0.0px 0.0px 0.0px 0.0px; font: 12.0px ‘Helvetica Neue’; min-height: 14.0px}THE COMPANY:ArcherDX, Inc.

www.ArcherDX.ComArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing.

By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification.

ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays.

ArcherDX is headquartered in Boulder, Colorado.

Learn more at www.Archerdx.Com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.POSITION SUMMARY :The Quality Assurance Specialist, reporting to a Quality Engineer, will support Personalized Cancer Monitoring (PCM) Manufacturing Quality activities in an ISO 13485 and GMP-regulated environment.

The individual must have a strong knowledge and application of the CFR and cGMP regulations to support the product launch.RESPONSIBILITIES:Provide direct QA support to Manufacturing Operations and process development for the ArcherDX PCM assay components and processes.Review and approve batch records (Travelers) for product release.Assist with validation activities (IQ/OQ/PQ) of processes, methods, and equipment.Support the creation of Standard Work, Line Balance, Work Content, and other analytical tools, and work with production teams to implementEnsure the Quality System elements are in compliance with the regulations, and help to create and/or drive improvements in the creation of Standard Operating Procedures for the manufacture of the new productCollaborate across Development, Operations, and Manufacturing teams to support actions that help ensure production readiness for new productsProvide QA support to create and maintain the production process in a validated stateMay support other Production-related activities including: raw materials receipt/transfer/release, labeling verification, kitting verification, QC report review, etc.Perform other duties as assigned by supervisorQUALIFICATIONS:2+ years of experience within quality assurance in (life sciences) medical device.Experience with 21CFR820, cGMP, and ISO13485 regulations.Knowledgeable of New Product Development activities and technology transfer to production in a regulated laboratory or manufacturing environmentExperience supporting and conducting process validationsLean/Six Sigma Certification preferredAttention to detail and ability to follow directions in modifying documentationAbility to interact and collaborate with multiple disciplines, and communicate clearly and effectively verbally and in writingAbility to work with minimal direction, and utilize good problem-solving skillsAbility to multitask and work within a fast-paced dynamic team environmentEDUCATION:Bachelor’s Degree in a scientific field