Quality Documentation Specialist — Regulated Systems

Us Tech Solutions; Collegeville (PA); On-site; USD 65,000 - 85,000; Full time

Job summary

US Tech Solutions is seeking a detail-oriented quality documentation professional for an 11-month contract in Collegeville, PA. You will manage controlled document lifecycles, coordinate reviews, and ensure audit-ready records within a regulated tech or life sciences environment.

Responsibilities include end-to-end documentation, stakeholder coordination, and strict adherence to quality processes, with exposure to GAMP 5, 21 CFR Part 11, and SDLC concepts.

Qualifications

• 3-5 years of experience managing controlled document lifecycles in regulated tech or life sciences.
• Familiar with GAMP 5 and 21 CFR Part 11 concepts.
• Strong technical writing with audit-ready records.
• Experience with QMS/eQMS or document management systems and version control.
• Proficient in coordinating reviews, approvals and sign-offs with stakeholders.
• Knowledge of SDLC in Agile/ Scrum or Waterfall environments.
• Awareness of cloud/security principles and data classification.
• Experience in pharma or life sciences regulatory contexts.
• Proficient with Jira and Confluence tooling.
• Understanding of IQ/OQ/PQ concepts beneficial.

Responsibilities

• Assist in end-to-end documentation lifecycle management for engineering, ensuring artifacts are produced, reviewed, approved and retained.
• Liaise with contributors to progress drafts, coordinate reviews and secure approvals.
• Support documentation reviews from a technical writing perspective and flag issues.
• Maintain repositories and version control for audit readiness and traceability.
• Support adherence to risk/issue management policies and report status to the Quality team.
• Manage routing and finalization of documents, including uploading and sign-offs.

Skills

Document lifecycle

Version control

Technical writing

Stakeholder follow-up

Risk & issue tracking

Quality partner collaboration

SDLC exposure

Information security awareness

Regulated industry experience

Jira & Confluence

Validation/GRC concepts

Education

Bachelor's Degree in a Scientific Discipline

Tools

Confluence

SharePoint

Job description

US Tech Solutions is seeking a detail-oriented quality documentation professional for an 11-month contract in Collegeville, PA. You will manage controlled document lifecycles, coordinate reviews, and ensure audit-ready records within a regulated tech or life sciences environment.

Responsibilities include end-to-end documentation, stakeholder coordination, and strict adherence to quality processes, with exposure to GAMP 5, 21 CFR Part 11, and SDLC concepts.