Quality Control Supervisor/Team Lead IVD (ADX-32-20) at ArcherDX
| Greater Boulder Area
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QUALITY CONTROL SUPERVISOR/TEAM LEAD IVD (ADX-32-20)
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.
The Quality Control Supervisor/Lead IVD oversees the development and implementation of quality control standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and functionality of products manufactured under Good Manufacturing Practices (GMPs) in the in-vitro diagnostic (IVD) manufacturing space. This role manages direct reports and conducts laboratory analysis.
RESPONSIBILITIES:
- 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.
KEY ATTRIBUTES:
- 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
EXPERIENCE:
- Minimum of 3 years experience in Quality Control in a regulated industry where GMPs are applied.
- Experience in a leadership position preferred
EDUCATION:
- BS/MS/PhD in molecular biology, biochemistry or related field and/or equivalent combination of education and experience
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