Senior Quality Assurance Auditor at Care Access Research | Powderkeg

Location: Remote, US

Employment Type: Full-time Employment

Team: Quality Assurance

What We Do

Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.

Who We Are

We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.

Position Overview

The Senior Quality Assurance Auditor role is a key member of the Quality Assurance team and provides support to all aspects of the Quality functions across the business. The role will support QA Management in assuring quality throughout the Company and will promote continual improvement processes to ensure all systems and procedures undertaken by Care Access are compliant with ICH-GCP Guidelines, and other applicable regulatory requirements. This role encompass a broad spectrum of activities, ranging from auditing systems and processes to collaborating with stakeholders and contributing to the organization's overall quality and regulatory compliance objectives.

What You'll Be Working On

Duties include but not limited to:

Conduct audits on quality systems and processes to ensure adherence to company policies, quality criteria, and applicable regulatory requirements and industry standards.

Internal routine audits and training to ensure consistency and compliance of Operations across all sites.

Complex audits, such as For-Cause audits, or process/ system audits at short notice.

Preparation and hosting external audits (e.g. conducted by Care Access Clients) and Regulatory Authority Inspections.

Act as the QA SME for Quality Issues. Attend cross-functional meetings and support Operational Compliance Teams with root cause analysis investigations (as required).

To work with Care Access personnel to improve and implement globally working practices and systems, in compliance with GCP and appropriate regulations to ensure best practices are achieved.

Act as the SME for business process improvement projects (as required).

Review existing quality standards and actively contribute to the development of programs aimed at enforcing and enhancing these standards.

To be an active part of the Quality Assurance team and work with the other members to plan and to manage the business, the culture, the values and the wellbeing of the company and its people so that the commercial objectives are achieved.

To develop Quality systems, processes and procedural improvements that deliver increased efficiency and other benefits.

Investigate, analyze, and ensure the accuracy of information in quality data collection tools, contributing to reliable data-driven decision-making.

Where requested by QA Management, provide effective training, coaching and mentoring, to junior members of the Quality Assurance department.

Where required, to peer review audit reports.

Conduct reviews of Care Access formal procedures to ensure alignment with quality standards and regulatory requirements.

Physical and Travel Requirements

This role requires up to 50% travel requirements. Length of travel will depend upon study requirements, staff needs, and company initiatives.

What You Bring

Knowledge, Skills, and Abilities:

Knowledge of the Clinical Trial Process

Knowledge of working to Quality systems and procedures in a regulated environment

Knowledge of international GCP regulations and regulatory inspections

Excellent analytical and communication skills and a proven track record of interacting with customers and/or suppliers

Computer skills in Microsoft Office applications are essential.

Be highly organized with a focus on quality and detail

Self-motivated with a high level of initiative

Open and clear communicator with excellent interpersonal skills

Ability to mentor junior staff Ability to work in a proactive and reactive environment

Ability to work with complex and difficult situations alone Good problem solving skills

Certifications/Licenses, Education, and Experience:

BSc Degree (life science) or equivalent qualification

Minimum five years’ experience in Clinical Quality Assurance within a CRO or Pharma organization or equivalent environment

Experience of performing clinical quality audits e.g. investigator site audits, process/ system audits, vendor audits.

Experience in validation of Computerized Systems would be an asset.

Experience of regulatory inspections e.g. MHRA, FDA Experience of sponsor/CRO audit process

Benefits (US Full-Time Employees Only)

PTO/vacation days, sick days, holidays.

100% paid medical, dental, and vision Insurance. 75% for dependents.

HSA plan Short-term disability, long-term disability, and life Insurance.

Culture of growth and equality 401k retirement plan

Diversity & Inclusion

We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success.

At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the

physicians and caring for patients.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

Care Access is unable to sponsor work at this time.

Job Summary
  • Job Title
    Senior Quality Assurance Auditor
  • Company
    Care Access Research
  • Location
  • Employment Type
    Full time
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