Assurance Specialist – Quality Documentation & SDLC

Assurance Specialist – Quality Documentation & SDLC Collegeville,PA Posted:10/14/2026 Job Description Job #: 8429

Location: Upper Providence, PA
Work Arrangement: Hybrid - Onsite approximately once per week or every other week
Schedule: Monday-Friday | 8-hour day shift Hourly Pay:$
Experience Level: Mid-Level (3-5 years preferred)

We are seeking a detail-oriented Assurance Specialist to support quality documentation, document lifecycle management, and compliance activities within a regulated technology and life sciences environment. The ideal candidate will bring a combination of quality documentation experience and working knowledge of the Software Development Life Cycle (SDLC). This position focuses on maintaining accurate, controlled, and audit-ready documentation while collaborating with Quality, Engineering, and cross-functional stakeholders.

This is a hands-on coordination and documentation support role, well-suited for a professional who enjoys managing details, maintaining compliance, and ensuring documentation progresses efficiently through established review and approval processes.

• Support the end-to-end documentation lifecycle for engineering activities, including document creation, review, approval, version control, and retention in accordance with established quality processes.
• Coordinate with Quality team members, engineers, and other stakeholders to obtain documentation, facilitate reviews, and secure timely approvals.
• Review technical documentation for accuracy, clarity, formatting, consistency, and completeness, escalating potential issues to the appropriate Quality team member.
• Maintain controlled documentation repositories and version histories to ensure traceability, compliance, and audit readiness.
• Track documentation deliverables, approval workflows, and outstanding actions, proactively following up with stakeholders to meet established deadlines.
• Assist with tracking deviations, corrective and preventive actions (CAPAs), risks, incidents, and other quality-related records through resolution.
• Support documentation associated with the Software Development Life Cycle (SDLC), including requirements, specifications, testing records, and release documentation.
• Coordinate document routing, uploads, approvals, and administrative finalization within established quality management systems.
• Provide regular progress updates, identify potential delays, and elevate documentation or compliance concerns to the assigned Quality team member.
• Collaborate with cross-functional teams, including international stakeholders, to support consistent documentation practices and quality standards.

Job Requirements

• Bachelor's degree in a scientific discipline or related field.
• Approximately 3-5 years of relevant experience in quality documentation, document control, technical documentation, or a related compliance-focused role.
• Hands-on experience managing controlled document life cycles within a Quality Management System (QMS), electronic QMS (eQMS), or comparable document management environment.
• Working knowledge of the Software Development Life Cycle (SDLC), including Agile, Scrum, or waterfall methodologies.
• Experience supporting or maintaining SDLC documentation, such as requirements, specifications, test records, or release documentation.
• Proficiency with document repositories and version control tools such as SharePoint, Confluence, or validated document management systems.
• Strong technical writing, proofreading, editing, and document formatting skills.
• Experience coordinating document reviews, tracking approvals, and following up with…