Assurance Specialist � Quality Documentation & SDLC
About The Position
The Assurance Specialist supports quality documentation, document lifecycle management, and compliance activities in a regulated technology and life sciences environment. The role maintains accurate, controlled, audit-ready documentation and supports the Software Development Life Cycle (SDLC), working with Quality, Engineering, and other stakeholders. It is a hands-on coordination and documentation support position focused on keeping documentation moving through established review and approval processes. The position is based in Upper Providence, Pennsylvania, with a hybrid arrangement requiring onsite attendance approximately once per week or every other week. The schedule is Monday through Friday, with an 8-hour day shift. Candidates must be legally authorized to work in the United States without current or future employer sponsorship and able to meet the hybrid onsite requirements. The employer is not accepting submissions from third-party staffing agencies, vendors, or consulting firms.
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 lifecycles within a QMS, eQMS, or comparable document management environment.
- Working knowledge of the 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 escalate issues appropriately.
- Legally authorized to work in the United States without employer sponsorship, now or in the future.
- Able to meet the hybrid onsite requirements in Upper Providence, Pennsylvania.
Nice To Haves
- 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.
- Organized, proactive approach to coordinating documentation across multiple teams.
- Comfort with hands-on documentation management, stakeholder coordination, and quality support.
Responsibilities
- Support the end-to-end documentation lifecycle for engineering activities, including document creation, review, approval, version control, and retention under 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 support traceability, compliance, and audit readiness.
- Track documentation deliverables, approval workflows, and outstanding actions; follow up with stakeholders to meet deadlines.
- Assist with tracking deviations, corrective and preventive actions (CAPAs), risks, incidents, and other quality-related records through resolution.
- Support SDLC documentation, including requirements, specifications, testing records, and release documentation.
- Coordinate document routing, uploads, approvals, and administrative finalization within established quality management systems.
- Provide progress updates, identify potential delays, and escalate 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
