Quality Control Supervisor/Team Lead IVD (ADX-32-20) at ArcherDX
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.
- Write, revise, review and/or approve QC documentation
- Supervises a team of Quality Technicians
- Supervise/Assist in conducting routine and non-routine analysis of raw materials, in-process and finished formulations according to SOP’s and WI’s
- Compiles data for documentation of test procedures and prepares reports
- Review data obtained for compliance to specifications and report abnormalities
- Perform a wide variety of inspections, checks, tests and sampling procedures for the manufacturing process
- Records detailed observations, analyzes data and interprets results
- Support QC material management including labeling, storage, lot control, inventory hold and release procedures
- Monitors critical equipment and instrumentation.
- Serve as a subject matter expert for various analytical procedures related to ArcherDX IVD products
- Leads component and finished product stability and validation projects
- Help develop and implement GMP quality processes and procedures, and programs to establish and ensure compliance with relevant ISO standards and FDA regulations.
- Participate on cross-functional project teams and/or working groups in various departments, as required to establish QC specifications for new products
- Participate in product development and design control activities as required
- Works collaboratively with QC functions in the Research Use Only (RUO) and Personal Care Monitoring (PCM)
- Perform other duties as
- 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.
- Attention to detail and desire for quality
- Strong time management skills (schedules, timelines, task prioritization) and the ability to adapt to changing priorities
- Excellent multi-tasking and problem-solving skills; solution-oriented; self-motivated
- Ability to participate with others as a member of the team to ensure success of cross-departmental projects, while, maintaining strong relationships within all parts of company
- Minimum of 3 years experience in Quality Control in a regulated industry where GMPs are applied.
- Experience in a leadership position preferred
- BS/MS/PhD in molecular biology, biochemistry or related field and/or equivalent combination of education and experience