Staffmark Group

Quality Assurance Specialist-Documentation

Cambridge, MA, US

Hybrid
Full-time
2 days ago
Save Job

Summary

Job Title: Quality Assurance Specialist - Documentation Location: Cambridge Full-Time :Hybrid ?? Industry: Pharmaceutical / Life Sciences Precision in documentation. Purpose in every page. We're seeking a detail-oriented and collaborative Quality Specialist - Documentation to join our pharmaceutical quality team. This role focuses on authoring and managing documentation critical to product quality, compliance, and regulatory success. Ideal for someone with 1-3 years of experience, this position offers the opportunity to grow within a quality-focused organization that values clear communication and continuous improvement. What You'll Do: * Own and manage documentation within our Document Control System (Veeva, LCMS, or similar) * Author, redline, and initiate creation and revisions of Finished Goods Specifications * Upload and maintain all relevant External Manufacturing documentation in the document control system * Draft and revise controlled documents including SOPs, work instructions, and quality records * Collaborate with cross-functional partners in QA, Regulatory, Manufacturing, and R&D to ensure accuracy and compliance * Assist with change control, audit readiness, and version management of key documentation * Translate complex processes into clear, compliant technical/procedural writing * Support document lifecycle tasks including routing, approval, release, and archiving What You Bring: * 1-3 years of experience in quality in a regulated environment * Experience working with Veeva, LCMS, or similar electronic document management systems (EDMS) * Proficient in technical writing, especially procedural content in regulated environments * Working knowledge of FDA/ICH guidelines and cGMP documentation standards * Detail-oriented with strong organizational and multitasking abilities * Clear, confident communicator who thrives in a supportive QA role * Proficient in Microsoft Office (Word, Excel, Outlook, PowerPoint) Preferred Qualifications: * Bachelor's degree in Life Sciences, Technical Writing, or a related field * Familiarity with Finished Goods Specifications and external manufacturing processes Why Join Us? We believe in the power of documentation to ensure product integrity, patient safety, and regulatory success. If you enjoy collaborating with teams, improving processes, and producing clear, compliant documents, you'll feel right at home. Apply today and help us uphold the highest standards in pharmaceutical quality-one document at a time. After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play.

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