Compliance Specialist - Level 2

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 / hour
Work Authorization: U.S. Citizens or Green Card holders only
Note: No third-party candidates will be considered

Key Responsibilities

• Partner 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