Specialist, Quality Assurance

How This Role Makes a Difference

Care Access is seeking a dedicated, experienced, and innovation-driven Quality Assurance Specialist (GxP) to support the success of the Quality Assurance Department and organizational compliance activities. The Quality Assurance Specialist will be responsible for closely monitoring the quality and compliance of clinical work at both traditional trial sites and decentralized trials.QA specialist will directly support of quality initiatives, audit functions, CAPA systems and promote inspections readiness.  Working in support of the Associate Director of Quality Assurance, the Quality Assurance Specialist will ensure that Care Access maintains a high level of quality while executing clinical trials according to Care Access SOPs, GCP, and FDA/ICH Guidelines.

How You'll Make An Impact

Site-Level Quality & Data Integrity: Ensure the highest standards of patient safety and data integrity at clinical research sites through regular quality assurance reviews, site quality support, and assurance compliance with Standard Operating Procedures.

GCP Regulatory Document Review: Conduct comprehensive reviews of study-specific regulatory binders and clinical documents to verify they are accurately completed and maintained per GCP standards.

Audit Execution & Tracking: Execute the yearly corporate audit plan, systematically tracking quality assurance audits, monitoring related activities, and preparing detailed outcome reports for management.

Issue Resolution & CAPA Management: Partner directly with research staff and Principal Investigators (PIs) to resolve identified compliance issues, developing, tracking, and monitoring Corrective and Preventative Action (CAPA) plans.

External Audit & Inspection Support: Coordinate and provide hands-on operational support for on-site audits and inspections conducted by external providers, sponsors, and regulatory agencies.

Quality Systems Administration: Provide ongoing administrative support to the Quality Department by maintaining internal quality systems, compliance trackers, and operational programs.

SOP Development & Maintenance: Participate in the routine review, drafting, and maintenance of quality assurance Standard Operating Procedures (SOPs) to ensure alignment with evolving regulations.

Cross-Functional Compliance Advisory: Act as an internal quality resource to provide ongoing guidance and best-practice recommendations to site personnel and clinical project teams.

Regulatory compliance: be knowledgeable of evolving GxP guidelines. Ability to critically think, eagerness to learn, and commitment to ensuring compliance. Knowledge of and able to interpret regulatory guidance’s such as 21 CFR Part 11/ Part 312, ICH GCP E6 (R3).

Inspection readiness: promote a culture of inspections readiness and continuous improvement. Be flexible to work with risk-based audit agendas and shifting priorities.

Create and deliver training on Quality and Improvement activities

Support completion of RFP/RFI (Request for proposals/information)

Willingness to learn and engage with digital technologies

Provide AI project quality support and consultation

Support other activities related to the management of QMS and accuracy of data

Support GxP and non GxP quality issues and/or projects needing quality consultation and support

The Expertise Required

Ability to work independently, remain objective, and manage multiple assignments.

Remain flexible and work in evolving regulatory environments.

Display an openness to innovative and compliant approaches to conducting research and health services activities

Technical proficiency is required to work daily in QMS and utilize various software and platforms across the business.

Ability to drive change and demonstrate impact across the business.

Excellent writing and presentation skills and ability to lead and coach staff and cross-functional teams.

Excellent working knowledge of medical and research terminology

Excellent working knowledge of federal regulations and Good Clinical Practices (GCP)

Attention to detail

Ability to communicate and work effectively with a diverse team of professionals

Strong Organizational Skills

Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients and vendors

Work effectively and collaboratively with other team members to accomplish mutual goals. Bring a positive and supportive attitude to achieving these goals

Demonstrate decision making skills

Curiosity and passion to learn, innovate, able to communicate any possible risks and get things done

Friendly, outgoing personality with the ability to maintain a positive attitude under pressure

High level of self-motivation and energy

Ability to work independently in a fast-paced environment with minimal supervision

Must have a client service mentality

Experience with supporting multiple sites and identifying gaps

Experience with internal and external audits: FDA, GCP, SOPs

Experience with supporting multiple sites and identifying improvement gaps

Certifications/Licenses, Education, and Experience

Minimum Education:

Bachelor’s degree

Minimum Experience:

2 years of experience in Quality Assurance

4 years of experience in Clinical Research working in a compliance or GCP relevant role

Portuguese and English language speaker required, Spanish is a plus.

How We Work Together

Location: Remote within the country, with some in-office presence required as needed

Travel: In-office/travel up to 25%

Benefits & Perks

Paid Time Off (PTO) and Company Paid Holidays

Medical, dental, and vision insurance plan options

#LI-Remote

Privacy Notice

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information, please review our Privacy Policy: https://careaccess.com/privacy-policy.

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consultar nossa Política de Privacidade para o Brasil:

https://careaccess.com.br/politica-de-privacidade.

Canada: Applicants in Canada can also review our Canada Privacy Policy:

https://careaccess.ca/privacy-policy

Poland: Applicants in Poland can also review our Poland Privacy Policy:

https://careaccess.pl/polityka-prywatnosci. Kandydaci w Polsce mogą również zapoznać

się z naszą Polityką prywatności dla Polski: https://careaccess.pl/polityka-prywatnosci.