Quality Assurance Specialist II/III (PCM) (ADX-255-20) at ArcherDX

| Greater Boulder Area
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Quality Assurance Specialist II/III (PCM) (ADX-255-20)
 
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COMPANY SUMMARY:
 
In October 2020, Invitae Corporation (NYSE: NVTA) combined with ArcherDX, a genomic analysis company specializing in cancer diagnostics and monitoring, to create a leading comprehensive medical and cancer genetics company. As a combined company, Invitae, is bringing world-class genetic testing and diagnostics into mainstream medicine to improve healthcare for billions of people. Our goal is to aggregate the world’s genetic tests into a single service with higher quality and accuracy, faster turnaround time and actionable results. Learn more at invitae.com and archerdx.com.
 
POSITION SUMMARY :
The Quality Assurance Specialist, reporting to a Quality Engineer, will support Personalized Cancer Monitoring (PCM) Manufacturing Quality activities in an ISO 13485 and GMP-regulated environment. The individual must have a strong knowledge and application of the CFR and cGMP regulations to support the product launch.
 
RESPONSIBILITIES:
  • Provide direct QA support to Manufacturing Operations and process development for the ArcherDX PCM assay components and processes.
  • Review and approve batch records (Travelers) for product release.
  • Assist with validation activities (IQ/OQ/PQ) of processes, methods, and equipment.
  • Support the creation of Standard Work, Line Balance, Work Content, and other analytical tools, and work with production teams to implement
  • Ensure the Quality System elements are in compliance with the regulations, and help to create and/or drive improvements in the creation of Standard Operating Procedures for the manufacture of the new product
  • Collaborate across Development, Operations, and Manufacturing teams to support actions that help ensure production readiness for new products
  • Provide QA support to create and maintain the production process in a validated state
  • May support other Production-related activities including: raw materials receipt/transfer/release, labeling verification, kitting verification, QC report review, etc.
  • Perform other duties as assigned by supervisor
QUALIFICATIONS:
  • 2+ years of experience within quality assurance in (life sciences) medical device.
  • Experience with 21CFR820, cGMP, and ISO13485 regulations.
  • Knowledgeable of New Product Development activities and technology transfer to production in a regulated laboratory or manufacturing environment
  • Experience supporting and conducting process validations
  • Lean/Six Sigma Certification preferred
  • Attention to detail and ability to follow directions in modifying documentation
  • Ability to interact and collaborate with multiple disciplines, and communicate clearly and effectively verbally and in writing
  • Ability to work with minimal direction, 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

  • 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

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
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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