Compliance Specialist - Level 2 US_AGS

Lancesoft; Collegeville (PA); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Lancesoft is seeking an Assurance Specialist in Collegeville, PA to support end-to-end documentation management for engineering projects. The role combines quality assurance with SDLC document control, requiring strong writing and articulation of regulatory-compliant artifacts.

The position is hybrid, onsite 1x a week or every two weeks at Upper Providence, with a 1-year contract duration. Ideal candidates have 3–5 years of relevant experience and excellent communication skills for audit-related

Qualifications

• Hands-on document lifecycle experience in a controlled environment (QMS, eQMS, or DMS).
• Experience maintaining repositories with traceability and audit readiness.
• Strong technical writing, proofreading and formatting skills for clarity and consistency.
• Proven ability to chase contributors, reviewers and approvers to meet deadlines.
• Experience tracking deviations, CAPAs, incidents, risks, or issues to closure.

Responsibilities

• Assist in end-to-end documentation lifecycle for engineering, ensuring artifacts are produced, reviewed, approved and retained.
• Coordinate reviews and secure requisite approvals with stakeholders and quality team.
• Provide technical writing support and flag issues during documentation review.
• Maintain repositories and version control to preserve audit readiness and traceability.
• Report progress and issues to the assigned Quality team member and ensure timely sign-offs.

Skills

Document lifecycle

Version control

Technical writing

Stakeholder follow-up

Risk/issue tracking

Quality partner collaboration

SDLC exposure

Info security awareness

Education

Bachelor's degree in a Scientific discipline

Tools

Jira

Confluence

Job description

Job Title: Assurance Specialist
Location: 1250 South Collegeville Road, Collegeville, PA 19426
Duration: 1 Year (09/15/2026 to 09/10/2027)
Shift: Day - 8 hours
Location: Upper Providence - Hybrid (onsite 1x a week or once every two weeks)

Job Description

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.

Education

Bachelors Degree in a Scientific Discipline

Additional Manager Feedback

Looking for someone 3-5 years relevant experience. Not intended for professionals with 10-20 years of experience who might be difficult to retain. Prior candidates were heavily focused on Quality backgrounds but lacked SDLC experience. Looking for candidates who are balanced between Quality and SDLC (software development lifecycle). Desired candidate to have strong written and verbal communication skills to the audit-related nature of the documentation. Also, ability to work independently. General awareness of validation concepts. Preference on EST candidates to cross collaborate with UK teams.

Essential

• 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.

Desirable Experience

• Desirable 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 computerised 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.