Assurance Specialist

Schedule:

08:00 AM - 5:30 PM

• Detail-oriented quality documentation professional with 3-5 years of experience managing controlled document life cycles in a regulated technology or life sciences environment. Skilled in document review, version control, stakeholder follow-up and tracking of risks, issues and CAPAs through to closure. Working knowledge of the SDLC and computerised systems validation concepts (GAMP 5, 21 CFR Part 11), with awareness of information and cloud security principles.
  
  Strong technical writing background, supporting senior quality colleagues in maintaining audit-ready, traceable records.

• In coordination with the assigned Quality team member, assist in managing the end-to-end documentation lifecycle for engineering, ensuring that required artifacts are produced, reviewed, approved and retained in accordance with applicable quality processes, and report progress or issues as needed for final review.
• Proactively liaise with contributors and stakeholders, in consultation with the assigned Quality team member, to progress draft documentation, coordinate reviews and secure requisite approvals.
• Provide support in documentation review from a technical writing perspective and flag suspected issues, collaborating with the assigned Quality team member where necessary.
• Maintain documentation repositories and version control practices to preserve audit readiness and traceability, keeping the assigned Quality team member informed of repository status and any version-control concerns.
• Support adherence to internal policies governing risk and issue management, including follow-up of outstanding or overdue records as assigned by the Quality team, and provide status updates to the assigned Quality team member.
• Manage document routing and administrative finalization (uploading, version tracking, coordinating sign-offs), in consultation with the assigned Quality team member.

• 3-5 years of experience.

• Document lifecycle:
  Hands-on experience routing documents through draft, review, approval and retention in a controlled environment (QMS, eQMS or document management system).
• Version control and repositories:
  Experience maintaining repositories (such as SharePoint, Confluence or a validated DMS) with traceability and audit readiness.
• Technical writing and editing:
  Proofreading, formatting and reviewing technical documents for clarity and consistency, and flagging suspected issues. A writing, English, communications or similar degree, or equivalent demonstrated experience, fits well.
• Stakeholder follow-up: A record of chasing contributors, reviewers and approvers to meet deadlines, escalating appropriately to a quality lead.
• Risk and issue record upkeep:
  Experience tracking deviations, CAPAs, incidents, risks or issues to closure, including overdue items, and providing status updates.
• Working with a quality partner:
  Comfortable supporting a more senior quality person, reporting progress and raising issues rather than owning decisions.
• SDLC exposure:
  Has worked within or alongside a software development lifecycle (Agile, Scrum or waterfall), for example by producing or managing documentation artifacts such as requirements, specifications, test records or release summaries.
• Information/cloud security awareness:
  Understands principles such as access control, data classification, confidentiality and shared responsibility in cloud environments. Certification is not required.
• Experience in a regulated industry (pharma, life sciences or similar) with 21 CFR Part 11 or Annex 11 familiarity
• Jira and Confluence, or comparable tools
• Validation/GRC concepts:
  Understands the basics of computerized systems validation, qualification and risk-based approaches, ideally GAMP 5 and the idea of a validated state. Hands-on authoring of IQ/OQ/PQ is not required.

• Bachelor's Degree in a Scientific Discipline
  .

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit  .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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