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

| Greater Boulder Area
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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.
 
 
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Technology we use

  • Engineering
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • D3JSLibraries
    • jQuery UILibraries
    • Twitter BootstrapLibraries
    • DjangoFrameworks
    • PostgreSQLDatabases

Location

Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

An Insider's view of ArcherDX

What’s the vibe like in the office?

Collaborative - when I walk through the ArcherDX office at any time of day, I can see cross-functional collaboration in action. Our team members are constantly connecting in structured and unstructured meetings to solve problems and achieve goals.

Sarah

Corporate Recruiter

How do you collaborate with other teams in the company?

Collaboration between functional groups is key to the Logistics team's success at Archer. Working closely with Sales, Manufacturing, Assay Development, Customer Support, Finance and QA allows us to provide better customer service by improving our processes, troubleshoot, brainstorm new ideas, learn from each other and share our best "dad" jokes.

Judy

Logistics Manager

How do you empower your team to be more creative?

Creativity requires a break from the routine and the screen. Here at Archer the team gets creative through walks to the food trucks, lunch runs, climbing gym sessions or a few end of the week craft brews. Some of our best algorithms were developed or refined on the climbing gym mat.

Aaron

VP of Bioinformatics and Commercial Development

How do your team's ideas influence the company's direction?

The marketing team brings in and drives the voice of our customers across the organization. Each strategic decision we make at ArcherDX is informed by a deep, customer-centric approach, where we use our insights to better understand how we can deliver an exceptional experience and aim to positively impact the lives of the patients we serve!

Ali

Director, Global Marketing

What are ArcherDX Perks + Benefits

ArcherDX Benefits Overview

ArcherDX offers a competitive and generous benefit package including:

• Medical PPO or HMO and Dental-82% of monthly premium covered by the company
• Optional vision, life, FSA, dependent care plans
• Basic AD&D, Short and Long Term disability-covered 100% by the company
• 160 hours PTO per calendar after three months of service
• 6-weeks parental leave covered 100% by the company
• 401K with company match with potential of up to $2000/year
• 2019 bonus - 5% based on company objectives (for non-commissioned employees)
• Company stock options for all employees
• Tuition Reimbursement
• Ecopass

Culture
Volunteer in local community
Partners with Nonprofits
Friends outside of work
Eat lunch together
Daily stand up
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Diversity
Documented equal pay policy
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Employees who have been with the company for 12 months are eligible for 12 weeks of family medical leave.
Company sponsored family events
Archer sponsors family oriented events annually. This year, we had our summer picnic at the Boulder Reservoir.
Vacation & Time Off Benefits
Generous PTO
Paid Holidays
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Cross functional training encouraged
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