Documents and Records Control Supervisor (ADX-364-20)

| Greater Boulder Area
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Document and Records Supervisor (ADX-364-20)
 

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 Document and Records Supervisor is responsible for ensuring compliant and efficient storage of records and management of change to those records. This position is the champion of the eQMS document repository and manages the document control team while establishing best practices for records retention and management. 
RESPONSIBILITIES:
  • Maintain a document control team utilizing both static and flexible resources to meet business needs for document generation, revision, storage and organization.
  • Ensure consistent access and business continuity regarding Archer’s eQMS system for managing quality records, validated quality processes and related backups.
  • Collaborate with partners within the quality department to optimize use of tools and records for easy demonstration of our quality system’s performance.
  • Perform a key role in supporting audits and inspections by speaking to the compliance of Archer’s maintenance of quality records and ensuring the audit team has easy access to all other documents needed for review by auditors and inspectors.
  • Collaborate with partners on Archer’s business continuity and disaster recovery plans.
  • Conduct, or provide content on, training on document control and good document practices for all employees.

EXPERIENCE:
  • Minimum 4 years of experience in quality engineering, document control or a related role.
  • One or more years of experience managing direct reports and resolving both employment issues as well as escalations from functional partners.
  • Strong working knowledge of 21 CFR 820 and ISO 13485:2016.
  • Collaborative and positive attitude.
  • Working knowledge of global regulatory submissions and typical content included therein.
  • Direct experience being interviewed in inspections and audits, and familiarity with audit support practices.
EDUCATION:
  • Minimum Bachelor’s degree.
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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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