Quality Control Supervisor/Team Lead RUO (ADX-33-20)
QUALITY CONTROL SUPERVISOR/TEAM LEAD RUO (ADX-33-20)
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 Control Lead/Supervisor oversees the development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and functionality of products manufactured as Research use only (RUO). This role manages direct reports and conducts laboratory analysis.
RESPONSIBILITIES:
- Supervise/Lead team of RUO QC techs
- Write, revise, review and/or approve QC documentation
- Conduct routine and non-routine analysis of raw materials, in-process and finished formulations according to SOP’s and WI’s
- Compile 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 RUO products
- Work with various departments to establish QC specifications for new products
- Help develop and implement quality control processes and procedures according to LEAN principles.
- 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 Personalized Cancer Medicine (PCM) and In-Vitro Diagnostic (IVD) space
- Perform other duties as assigned
- 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 and efficiency
- 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 setting.
- 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