Quality Assurance Specialist I (PCM) (ADX-279-20)
Quality Assurance Specialist I (PCM) (ADX-279-20)
THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
ArcherDX 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 implement
- Ensure 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 product
- Collaborate across Development, Operations, and Manufacturing teams to support actions that help ensure production readiness for new products
- Provide QA support to create and maintain the production process in a validated state
- May 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 supervisor
QUALIFICATIONS:
- 0-2 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 environment
- Experience supporting and conducting process validations
- Lean/Six Sigma Certification preferred
- Attention to detail and ability to follow directions in modifying documentation
- Ability to interact and collaborate with multiple disciplines, and communicate clearly and effectively verbally and in writing
- Ability to work with minimal direction, and utilize good problem-solving skills
- Ability to multitask and work within a fast-paced dynamic team environment
EDUCATION:
- Bachelor’s Degree in a scientific field