Quality Control Coordinator (ADX-121-20)
ArcherDX (Boulder, CO) is a fast-growing molecular technology company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine and offer a robust platform for detecting variants associated with cancers and inherited diseases.
The Quality Control (QC) Coordinator, reporting to the Director, MQE, will help develop, implement and maintain stability programs, method validation programs and QC equipment in the production of ArcherDX’s IVD medical devices in compliance with Good Manufacturing Practices (GMPs), relevant ISO standards, and FDA regulations.
- Manage/assist with the development and implementation of procedures associated with stability, method validation and QC equipment use.
- Prepare, review and revise stability plans, protocols, and reports with input from IVD Development and Statistics groups.
- Ensure that all stability samples are pulled and analyzed per procedure requirements.
- Coordinate and plan QC testing for stability studies in the IVD QC laboratories according to Archer procedures.
- Manage method validation program including scheduling validation activities in the QC laboratory and writing/revising QC methods.
- Review QC data obtained from stability study and method validation testing for compliance to specifications and initiate OOS investigations where appropriate.
- Manage non-conformance reports and deviations associated with stability, method validation and QC equipment.
- Assist with training staff members in areas of stability and method validation.
- Manage the change control process within QC as it pertains to stability, methods and QC equipment.
- Ensure laboratory equipment is maintained and qualified according to internal procedures.
- May perform QC testing as needed.
- Participate on project teams and/or working groups, as required
- Maintain compliance with all company policies, quality systems, and procedures
- Perform other duties as assigned by supervisor
- Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures.
- Safeguarding the privacy and security of protected health information and European Union personal data.
- Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology.
- Minimum of 5 years experience with FDA and/or ISO standards and regulations in a GMP environment in either a Quality Assurance or Quality Control role.
- Minimum of 3 years of direct experience coordinating and/or implementing stability and/or method validation programs
- Attention to detail with an ability to technically create and review documentation
- Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing
- Ability to work independently, and utilize good problem-solving skills
- Ability to multitask and work within a fast-paced dynamic team environment
Bachelor's degree in a scientific field
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