Alphanumeric is hiring a Compliance Specialist - Level 2 to support our long-standing client 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.