Senior Research Quality Analytics Specialist (ADX-329-20) at ArcherDX

| Greater Boulder Area
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Senior Research Quality Analytics Specialist (ADX-329-20)
 
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 Senior Quality Analytics Specialist will lead diverse cross-functional teams in the pursuit of quality analytical services in compliance with appropriate regulations such as GMP (good manufacturing practice), GLP (good laboratory practice), and GCP (good clinical practice). Areas of direct influence will include, but not be limited to, quality control testing, test method validation, tech transfer, process validation, continual process improvement, product stability program design and execution, laboratory management, product specifications, and risk assessments. This role shall provide strategic leadership to establish and maintain quality levels that consistently deliver best-in-class products that comply with US FDA Regulations, as well as Regulations of OUS markets and manufacturing sites. 
RESPONSIBILITIES:
  • Identify and lead continuous process improvement initiatives that improve the customer experience, enhance workflow, business and manufacturing processes and/or improve the work environment. 
  • Liaise with early discovery and development partners to drive the continuous flow of knowledge from manufacturing to early research speeding development and reducing time to market for new products.
  • Organize and oversee management of Quality principles for SPC, Quality-by-Design (QBD), Quality Control, Test Method and Process Validation, Tech Transfer and stability teams, including the review and approval of protocols and reports.
  • Foster a strong QBD culture striving for continuous quality improvement throughout the entire company.
  • Engage in driving the quantitative assessment of specification setting, release limits, process monitoring metrics, and risk assessments.
  • Provide strategic analytical leadership throughout the product development process and ensure strong quality domain representation in product development and manufacturing services teams
  • In conjunction with cross functional leaderships develop appropriate metrics, and tools for data collation.
  • Oversee investigations of laboratory issues to insure timely, closed loop corrective actions and reports as required through CAPAs.
  • Lead by example to create an inclusive culture that values high engagement driven to continuous improvement.
  • Participate in the development of education and training programs for quality initiatives, such as quality-by-design (QBD), utilization of Design-of-Experiments (DOEs), SPC and quality monitoring.

 KEY ATTRIBUTES:
  • Passion for enhancing healthcare outcomes with novel technology.
  • Problem solver, comfortable operating in the grey-space and driving forward with risk balanced decision making.
  • History of thriving in a fast-paced, dynamic environment.
  • Inspirational team player with a passion for science and driving to solutions.
  • Self-starter:
    • Driven to perform
    • Self-directed, curious, and motivated to understand the business, technical, scientific and regulatory aspects of the business.
    • Able to organize and prioritize
    • Strong leadership and communication skills

EXPEREINCE:
  • Minimum of 5-10 years experience in two or more of the following areas is required: quality, regulatory, laboratory experience, statistics, six-sigma, engineering.
  • Knowledge of biology, genetics, familiarity with genomic data, proficiency in molecular techniques, NGS preferred.
  • Working knowledge of cGMP/CFR/FDA regulations, with knowledge of OUS regulations.
  • Experience with applicable FDA regulations and ISO standards, working knowledge of international regulations strongly preferred

EDUCATION:
  • A minimum of a master’s degree in statistics, genetics, or related field is required
  • Advanced Degree preferred
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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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