Quality Assurance Consultant

Location: Remote (Client based on East Coast, USA)

Duration: 12 Months

Start Date: ASAP

We are seeking an experienced Quality Assurance (QA) Consultant for a 12-month remote engagement with a life sciences client based on the East Coast. This consultant will play a key role in supporting, maintaining, and enhancing Quality Management System (QMS) processes. The ideal candidate will bring strong experience in quality systems, operational support, and documentation practices within regulated environments.

Responsibilities

• Maintain, support, and enhance the client’s Quality System processes.
• Support daily operational QA activities and continuous improvement initiatives.
• Assist in the implementation and optimization of quality system tools and platforms.
• Help ensure compliance with 21 CFR Part 11 and other regulatory standards.
• Provide administrative support and configuration knowledge in systems such as Veeva QDocs, ComplianceWire, and DocuSign (Part 11 compliant).
• Collaborate with cross-functional teams on QMS projects, including Supplier Quality, Document Control/Records Management, and Training.
• Contribute to SOP development, review, and revision processes.
• Ensure accurate documentation and support audit readiness.

Qualifications

• 8 years of experience in Quality Assurance or Quality Systems within a regulated environment (e.g., life sciences, biotech, pharma).
• Experience administering or working with QMS tools such as Veeva QDocs, ComplianceWire, DocuSign Part 11, Smartsheet, and the Microsoft Office Suite.
• Strong attention to detail and commitment to quality and compliance.
• Proven ability to problem-solve and adapt to new systems and tools quickly.
• Excellent organizational skills and ability to manage multiple priorities.
• Strong interpersonal skills with clear, effective, and professional communication.
• Prior experience supporting supplier quality, document control, and training processes is highly desirable.