Pharma Compliance & Documentation Specialist

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

Job summary

Alphanumeric Systems Inc. in Collegeville, PA, seeks a Compliance Specialist to support Quality and Engineering in a regulated pharmaceutical environment. You will assist with controlled documentation, SDLC-related tasks, and CSV activities to ensure audit-ready records.

The role emphasizes hands-on administrative support across stakeholders, with an emphasis on documentation lifecycle, traceability, and conformity to quality processes. Applicants must be eligible to work on a W2.

Qualifications

• Bachelor's degree in a scientific discipline is 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.

Responsibilities

• Assist in managing the end-to-end documentation lifecycle for Engineering and computerized systems, ensuring artifacts are produced, reviewed, approved, and retained per Quality processes.
• Coordinate with authors, reviewers, and stakeholders to progress drafts, reviews, approvals, and overdue actions.
• Support documentation and administrative activities related to the Software Development Lifecycle (SDLC).
• Assist with documentation supporting CSV and governance, risk, and compliance activities for developed or computerized systems.
• Support controlled documentation associated with system lifecycle activities, including requirements, testing/validation, changes, approvals, and records.
• Review documentation for clarity, gaps, or compliance issues and escalate as needed.
• Maintain controlled-document repositories and version-control for traceability and audit readiness.
• Manage document routing and finalization, including uploading, version tracking, reviews, sign-offs, and retention.

Skills

Detail-oriented

Documentation

Quality Systems

CSV

GRC

SDLC

Regulatory compliance

Written communication

Cross-functional collaboration

Education

Bachelor's degree in a scientific discipline

Tools

Electronic Document Management System (EDMS)

Quality Management Software

CSV tooling

Job description

Alphanumeric Systems Inc. in Collegeville, PA, seeks a Compliance Specialist to support Quality and Engineering in a regulated pharmaceutical environment. You will assist with controlled documentation, SDLC-related tasks, and CSV activities to ensure audit-ready records.

The role emphasizes hands-on administrative support across stakeholders, with an emphasis on documentation lifecycle, traceability, and conformity to quality processes. Applicants must be eligible to work on a W2.