Coordinator, Quality Control (ADX-21-20)

| Greater Boulder Area
Quality Control Coordinator (ADX-121-20)
 
COMPANY:
 
ArcherDX (Boulder, CO) is a fast-growing molecular technology company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine and offer a robust platform for detecting variants associated with cancers and inherited diseases.
 
POSITION SUMMARY:
 
The Quality Control (QC) Coordinator, reporting to the Director, MQE, will help develop, implement and maintain stability programs, method validation programs and QC equipment in the production of ArcherDX’s IVD medical devices in compliance with Good Manufacturing Practices (GMPs), relevant ISO standards, and FDA regulations.
 
RESPONSIBILITIES:
  • Manage/assist with the development and implementation of procedures associated with stability, method validation and QC equipment use.
  • Prepare, review and revise stability plans, protocols, and reports with input from IVD Development and Statistics groups.
  • Ensure that all stability samples are pulled and analyzed per procedure requirements.
  • Coordinate and plan QC testing for stability studies in the IVD QC laboratories according to Archer procedures. 
  • Manage method validation program including scheduling validation activities in the QC laboratory and writing/revising QC methods.
  • Review QC data obtained from stability study and method validation testing for compliance to specifications and initiate OOS investigations where appropriate.
  • Manage non-conformance reports and deviations associated with stability, method validation and QC equipment.
  • Assist with training staff members in areas of stability and method validation.
  • Manage the change control process within QC as it pertains to stability, methods and QC equipment.
  • Ensure laboratory equipment is maintained and qualified according to internal procedures.
  • May perform QC testing as needed.
  • Participate on project teams and/or working groups, as required
  • Maintain compliance with all company policies, quality systems, and procedures
  • Perform other duties as assigned by supervisor
  • 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.
QUALIFICATIONS
  • Minimum of 5 years experience with FDA and/or ISO standards and regulations in a GMP environment in either a Quality Assurance or Quality Control role.
  • Minimum of 3 years of direct experience coordinating and/or implementing stability and/or method validation programs
  • Attention to detail with an ability to technically create and review documentation
  • Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing
  • Ability to work independently, and utilize good problem-solving skills
  • Ability to multitask and work within a fast-paced dynamic team environment
EDUCATION:
 
Bachelor's degree in a scientific field
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Technology we use

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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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