QC Tech Transfer and Training Manager (ADX-246-20)

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 QC Tech Transfer and Training Manager, reporting to the Associate Director of QC, will transition assay development knowledge and procedures to QC work instructions and training programs facilitating robust QC testing to ensure quality manufacturing products are released to Archer customers. They will provide leadership to establish and maintain quality levels that meet and exceed customer expectations. Function includes development of training program(s) for regulated and RUO products; assurance that relevant procedures (work instructions, forms, and training program(s) are managed and continuously reviewed and improved for compliance and operating efficiencies; ensures that QC department personnel are trained and component to perform testing; ensures compliance to medical device and in vitro diagnostic regulations, relevant to the scope of department.

RESPONSIBILITIES:

Job performance will involve a variety of activities including:

• In coordination with the Associate Director of QC, develop and continuously improve QC department training program(s) for regulated and RUO products.
• Build comprehensive and clear QC work instructions and forms to ensure continuity in QC testing across the department and continuously improve to meet growing demands.
• Act as a liaison with the Assay Development and Manufacturing departments to acquire new product/assay knowledge in order to facilitate seamless integration/transition of new Archer products into the QC testing laboratory.
• Assist in the implementation of a proficiency testing program for QC testing personnel.
• Maintenance of QC personnel training and proficiency testing records.
• Under guidance of the Associate Director of QC, organize the QC laboratory space for quality and efficiency in order to meet regulatory requirements while allowing for a scalable testing and training environment.
• Execution of work instructions testing in-process raw, sub-assembly, and top level materials.
• Critical analysis of data ensuring compliance with standards and working cross functionally to assist in data collection and trending analysis.
• Generation of data reports and release of materials.
• Adherence to safety and quality laboratory standards.
• Assist QC Coordinator in maintaining laboratory material stocks and initiating re-orders, completing equipment maintenance, and equipment acquisition.
• Execution of validation protocols.
• Identification of non-conforming material, investigation, and subsequent report initiation and generation.
• Perform other duties as assigned by supervisor
• Review, understanding, and compliance with ArcherDX HIPAA security polices and procedures.

EXPERIENCE:

• Minimum of 10 years’ experience in laboratory testing/Quality Assurance/Quality Control
• Previous laboratory experience with NGS and molecular testing
• Knowledge of cGMP/CFR/FDA regulations
• Previous demonstration of management/training skills
• Strong leadership and communication skills

KEY ATTRIBUTES:

• Drive and determination
• Ability to work in a fast paced and dynamic environment
• Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
• Strong communication and presentation skills
• Self-starter
  • Driven to perform
  • Self-directed: needs little explicit direction
  • Able to organize, prioritize, and delegate tasks to efficiently move projects forward

EDUCATION:

• Bachelor's degree required.