GCP Quality Assurance Specialist II/III (ADX-60-20)

| Greater Boulder Area
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GCP/GLP Quality Assurance Specialist II/III (ADX-60-20)
 

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 GCP/GLP QA Specialist II/III is responsible for the development, coordination, and implementation of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) -related requirements into our quality management system SOPs and practices. This is applicable to clinical trials being conducted using ArcherDX Next-Generation Sequencing (NGS) diagnostic test kits independently as the Sponsor and in partnership with pharmaceutical organizations. Specifically, responsibilities include:
 
RESPONSIBILITIES:
  • Development of departmental processes and procedures as well as reviewing and providing input on cross-functional processes and procedures as they relate to Good Clinical Practices and GLP Practices.
  • Review and approve clinical trial documentation (e.g. protocols, reports, internal deviations and associated CAPAs, etc.)
  • Development and implement risk-based audit strategies focused on internal and external Good Clinical Practice (GCP) audits (internal processes, external GCP vendors and clinical investigator sites) to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, GLP guidelines, ArcherDX procedures, clinical trial protocols and partnership agreements
  • Align audit practices with ArcherDx Internal and 2nd Party Audit activities.
  • Develop and implement GCP inspection readiness plans (customer and regulatory body)
  • Communicate audit outcomes, effectively including timely monitoring of completion of the agreed corrective and preventive actions, aligning with the ArcherDx CAPA program.
  • Compile metrics, measure trends and identify improvements based on defined process descriptions and KPIs.
  • Document and drive mitigations related to GCP corporate risk and escalate serious non-compliance situations.
  • Build GLP requirements into current QMS.
  • Attend meetings internally and externally, as well as investigator meetings as needed, to represent quality assurance expectations and GCP training.
  • Represent GLP/GCP Quality Assurance on compliance-related projects and initiatives
  • Remain current with the latest industry changes to regulatory requirements and industry standards within the US and ex-US as appropriate.
  • Effectively apply the ArcherDx quality systems (training, procedures, internal deviations, CAPA) within the various clinical research and associated support functions.
  • Drive productive, dynamic, professional working relationships with colleagues in other Quality Assurance functions and other GLP/GCP-impacted departments.
  • Perform other duties as assigned.
  • 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:
  • Demonstrated knowledge of the device development process (early through late stages), trial design, data and trial management procedure
  • Current and strong working knowledge and application of national and international GCP regulations, guidance and compliance initiatives.
  • Ability to compile and interpret quality metrics.
  • Excellent verbal and written communication skills with the ability to work well in teams or independently and able to prioritize work, manage multiple projects while maintaining quality.
  • Strong analytical and writing skills to identify issues, solve problems and document them appropriately.
  • Strong organizational and project management skills, attention to detail, and professionalism required.
  • Ability to prioritize and coordinate multiple projects and assignments in a demanding fast-paced environment with changing priorities and activities.
  • Ability to influence others as part of a collaborative team and negotiate effective solutions; strong interpersonal and social skills.
 
EXPERIENCE:
  • A minimum of 3+ years of relevant and increasingly responsible experience in the Biotech/Pharmaceutical/Medical Device Industry in a GCP quality role, clinical monitoring or equivalent with at least 1 of those years in quality.
  • GCP auditing experience is required.
  • Previous participation in regulatory authority inspections is highly desired.
EDUCATION:
  • BS/MS in a scientific or life science discipline, or equivalent experience.
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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
Promote from Within
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