- Salary
- $41 – $45/hr
- Location
- Collegeville, Pennsylvania, US
- Type
- Contract
- Department
- Legal
- Education
- Bachelor
- Visa
- Not sponsored
- Source
- BetterTeam
Description
Compliance Specialist - Collegeville, PA
Alphanumeric is hiring a COMPLIANCE SPECIALIST to work in Collegeville, PA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements.
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.
Position Overview:
The Compliance Specialist will provide administrative and documentation support to Quality and Engineering teams within a regulated pharmaceutical environment. This role will assist with the end-to-end lifecycle of controlled documentation and support compliance activities associated with computerized systems, software development lifecycle (SDLC), computer systems validation (CSV), and governance, risk, and compliance (GRC) processes.
The ideal candidate will have experience working with controlled documentation in a regulated environment and familiarity with computerized system lifecycle and validation concepts. This is a hands-on support position and is not intended to be a senior-level technical or leadership role.
Key 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.
Ideal Candidate:
- The ideal candidate is a detail-oriented Compliance, Quality Systems, CSV, Validation, or documentation professional who understands regulated documentation and has exposure to the lifecycle of computerized systems.
- This individual does not need to be a senior CSV, software development, cybersecurity, or IT professional.
- The role is intended to provide hands-on administrative and documentation support, coordinate activities across stakeholders, track deliverables, and help ensure required records remain complete, controlled, traceable, and audit-ready.
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 escalate appropriately.
- Experience with electronic document management, Quality Management, or validation systems is preferred.
- Pharmaceutical, biotechnology, life sciences, or other regulated-industry experience preferred.
Skills
CybersecurityComplianceTechnical WritingChange Management
