Compliance & Documentation Specialist, CSV & SDLC

Alphanumeric Systems; Collegeville (PA); On-site; USD 56,000 - 62,000; Full time

Job summary

Alphanumeric Systems is seeking a Compliance Specialist in Collegeville, PA to support the end-to-end documentation lifecycle for Engineering and computerized systems in a regulated pharmaceutical environment.

The role focuses on ensuring artifacts are produced, reviewed, and retained with quality processes, while coordinating with Quality, IT, and Validation teams to maintain audit readiness and data integrity.

Qualifications

• Bachelor's degree in a scientific discipline required.
• Experience supporting Quality, Compliance, Engineering, Validation, IT/Technology, or controlled documentation within a regulated environment.
• Experience supporting or managing aspects of the Software Development Lifecycle (SDLC).
• Familiarity with Computer Systems Validation (CSV) and/or governance, risk, and compliance concepts as they relate to developed or computerized systems.
• General awareness of information security and cloud security principles.
• Understanding of controlled-document lifecycle management, including review, approval, version control, routing, retention, and audit readiness.
• Strong organizational and follow-up skills with the ability to coordinate documentation across multiple stakeholders.
• Strong written communication, technical writing, and documentation-review skills.
• Ability to identify documentation inconsistencies or potential compliance issues and elevate appropriately.
• Experience with electronic document management, Quality Management, or validation systems is preferred.
• Pharmaceutical, biotechnology, life sciences, or other regulated-industry experience preferred.

Responsibilities

• In coordination with the assigned Quality team member, assist in managing the end-to-end documentation lifecycle for Engineering and computerized systems, ensuring required artifacts are produced, reviewed, approved, and retained in accordance with applicable Quality processes.
• Proactively coordinate with document authors, contributors, reviewers, and other stakeholders to progress draft documentation, facilitate reviews, obtain required approvals, and follow up on outstanding actions.
• Support documentation and administrative activities associated with aspects of the Software Development Lifecycle (SDLC).
• Assist with documentation supporting Computer Systems Validation (CSV) and/or governance, risk, and compliance activities for developed or computerized systems.
• Support controlled documentation associated with system lifecycle activities, including applicable requirements, reviews, testing/validation, change activities, approvals, and system records.
• Review documentation from a technical-writing and document-quality perspective, identifying potential gaps, inconsistencies, or compliance concerns and escalating them to the assigned Quality team member as appropriate.
• Maintain controlled-document repositories and version-control practices to support traceability, data integrity, audit readiness, and appropriate record retention.
• Manage document routing and administrative finalization, including uploading documents, tracking versions, coordinating reviews and sign-offs, and ensuring completed records are appropriately retained.
• Support adherence to internal policies governing risk, issue, and change management, including follow-up on outstanding or overdue records and communication of status to Quality stakeholders.
• Assist with tracking documentation progress, identifying bottlenecks, and providing status updates or metrics as required.
• Work cross-functionally with Quality, Engineering, IT/Technology, Validation, and other stakeholders to support compliant documentation and system lifecycle activities.
• Apply an awareness of information security and cloud security principles when supporting documentation and compliance activities for computerized systems.

Skills

Detail-oriented

Documentation control

SDLC familiarity

CSV awareness

Quality systems

Cross-functional collaboration

Written communication

Education

Bachelor's degree in a scientific discipline

Tools

Electronic document management

Quality Management software

Job description

Alphanumeric Systems is seeking a Compliance Specialist in Collegeville, PA to support the end-to-end documentation lifecycle for Engineering and computerized systems in a regulated pharmaceutical environment.

The role focuses on ensuring artifacts are produced, reviewed, and retained with quality processes, while coordinating with Quality, IT, and Validation teams to maintain audit readiness and data integrity.