Alphanumeric is hiring a Compliance Specialist - Level 2 to support our long-standing client in Collegeville, PA committed to improving lives through medical and pharmaceutical advancements. This role will focus on documentation lifecycle management, compliance support, and audit readiness within a regulated environment.
Pay Range: $40-45 / hourWork Authorization: U.S. Citizens or Green Card holders onlyNote: No third-party candidates will be consideredKey ResponsibilitiesPartner with assigned Quality team members to support the end-to-end documentation lifecycle for engineering and compliance-related records
Ensure required documentation is created, reviewed, approved, and retained in alignment with applicable quality standards and processes
Proactively coordinate with cross-functional stakeholders to advance documentation, manage reviews, and secure approvals
Perform documentation reviews from a technical writing and compliance perspective, identifying gaps or inconsistencies and escalating as needed
Maintain document repositories and enforce version control best practices to ensure audit readiness and traceability
Support compliance with internal policies related to risk and issue management, including tracking and following up on outstanding records
Manage document routing and administrative finalization activities, including uploading, version tracking, and coordinating approvals/signatures
Provide regular updates to the Quality team on documentation status, risks, and any compliance concerns
Required Qualifications
- Bachelor's Degree in a Scientific discipline (e.g., Biology, Chemistry, Engineering, Life Sciences, or related field)
- 2+ years of experience in a regulated environment (pharmaceutical, biotech, medical device, or similar)
- Experience supporting documentation lifecycle management within quality or compliance frameworks
- Strong understanding of GxP principles, document control, and audit readiness practices
- Excellent organizational, communication, and stakeholder coordination skills
- High attention to detail with the ability to manage multiple priorities and deadlines
Preferred Qualifications
- Experience working with electronic document management systems (EDMS)
- Familiarity with engineering documentation in a regulated setting
- Technical writing or documentation review experience
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Alphanumeric Systems, Inc