Assurance Specialist - Quality Documentation & SDLC
Location: Upper Providence, Collegeville, PA
Work Arrangement: Hybrid - Onsite approximately once per week or every other week
Hourly Pay: $41.00-45.00
Experience Level: Mid-Level (3-5 years preferred)
About the Opportunity:
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.
Key Responsibilities:
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 escalated 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.
Required Qualifications: 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 lifecycles 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 multiple stakeholders.
Familiarity with quality-related risk and issue tracking, including deviations, CAPAs, or similar records.
General understanding of computerized systems validation concepts and documentation requirements.
Awareness of information security and cloud security principles, including access controls, confidentiality, and data classification.
Excellent written and verbal communication skills, with strong attention to detail.
Ability to work independently, prioritize competing deadlines, and elevate issues appropriately.
Preferred Qualifications:
Experience supporting quality documentation in pharmaceutical, biotechnology, life sciences, or another regulated industry.
Familiarity with 21 CFR Part 11, EU Annex 11, or GAMP 5 guidelines.
Experience using Jira, Confluence, or comparable project and documentation management tools.
Understanding of computerized systems validation (CSV), qualification processes, and risk-based validation approaches.
Familiarity with Governance, Risk, and Compliance (GRC) concepts.
Experience collaborating with international or UK-based teams.
Availability to work primarily during Eastern Time business hours to facilitate cross-functional collaboration.
What Makes a Successful Candidate?
The successful candidate will be organized, proactive, and comfortable coordinating documentation across multiple teams. They will understand the importance of controlled documentation in regulated environments and possess sufficient SDLC knowledge to recognize and support software-related documentation requirements.
This position is particularly suited for someone who enjoys hands-on documentation management, stakeholder coordination, and quality support rather than primarily strategic leadership or highly specialized validation engineering.
Additional Requirements
Work Authorization:
Applicants must be legally authorized to work in the United States without employer sponsorship, now or in the future.
Third-Party Submissions: We are not accepting applications or candidate submissions from third-party staffing agencies, vendors, or consulting firms.
Candidates must be able to meet the hybrid onsite requirements in Upper Providence, PA.
