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Compliance Specialist

Location: Collegeville, PA
Pay Range: $41.50 – $45.20/hour

Please Note: We are unable to accept applications from third-party vendors, and we do not offer sponsorship. Applicants must be eligible to work on our W2 without requiring sponsorship now or in the future.

Alphanumeric is hiring a COMPLIANCE SPECIALIST to work in Collegeville, PA with our client of 20 years, a global leader committed to improving lives through medical and pharmaceutical advancements.

We are seeking a detail-oriented Compliance Specialist to support Quality and Engineering documentation activities within a regulated pharmaceutical environment. This position will help manage the end-to-end documentation lifecycle, coordinate reviews and approvals, maintain document control and traceability, and support ongoing audit readiness.

Key Responsibilities:

Partner with Quality team members to support the end-to-end lifecycle of engineering documentation, ensuring required records and artifacts are created, reviewed, approved, finalized, and retained in accordance with established quality processes.
Coordinate with contributors and cross-functional stakeholders to advance draft documentation, facilitate reviews, resolve outstanding actions, and obtain required approvals.
Review documentation from a technical writing and documentation-quality perspective, identifying inconsistencies, gaps, or potential compliance concerns and escalating issues to the appropriate Quality team member.
Maintain controlled documentation repositories and appropriate version-control practices, supporting traceability, document integrity, and audit readiness.
Support compliance with internal policies and procedures related to risk, issue, and record management, including follow-up on outstanding or overdue documentation.
Track documentation status, outstanding actions, approvals, and other deliverables and provide timely updates to Quality stakeholders.
Manage document routing and administrative finalization, including uploads, version tracking, approval coordination, and sign-offs.
Collaborate with Quality, Engineering, and other stakeholders to help ensure documentation is accurate, complete, appropriately controlled, and inspection-ready.

Qualifications:

Bachelor's degree in a scientific discipline required.
Experience supporting Quality, Compliance, Engineering, or controlled documentation within a regulated environment strongly preferred.
Experience in the pharmaceutical, biotechnology, life sciences, or other GxP-regulated industry preferred.
Understanding of document lifecycle management, document control, version control, and approval workflows.
Strong technical writing, proofreading, and documentation-review skills.
Excellent organizational skills with the ability to manage multiple documents, deadlines, and stakeholders simultaneously.
Strong attention to detail and ability to identify documentation inconsistencies or potential compliance issues.
Effective written and verbal communication skills with the ability to work cross-functionally.
Experience maintaining documentation in an electronic document management or quality management system is preferred.

Ideal Candidate

The ideal candidate combines strong documentation and organizational skills with experience working in a regulated Quality environment. They should be comfortable coordinating across Quality and Engineering teams, following up on outstanding documentation, maintaining accurate version control, and ensuring records remain complete, traceable, and audit-ready.

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