Stark Associates LLC
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 clients 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.
Seniority level
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Seniority level
Mid-Senior level Employment type
Employment type
Full-time Job function
Job function
Quality Assurance Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Stark Associates by 2x Sign in to set job alerts for Quality Assurance Consultant roles.
Manager, Quality Assurance (QA), Global QMS
Canton, MA $70,000.00-$90,000.00 2 weeks ago Quality Assurance Engineer-CMM exp required - Manufacturing Co.
Beverly, MA $80,000.00-$110,000.00 19 hours ago Quality Assurance Engineer - Medical Device
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Acton, MA $68,700.00-$103,050.00 1 week ago Assurance Manager, Quality Management - IS Assurance
Boston, MA $100,000.00-$150,000.00 2 weeks ago Quality Assurance Specialist/Manager Bioanalytical Laboratory
Woburn, MA $120,000.00-$140,000.00 1 week ago Quality Assurance Engineer, Manufacturing
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Boston, MA $70,900.00-$105,000.00 3 weeks ago Cambridge, MA $67,151.00-$79,460.00 1 week ago Boston, MA $130,000.00-$140,000.00 14 hours ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr