Compliance Specialist
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Overview
Job Description
- 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.
- 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.
- Experience working with electronic document management systems (EDMS).
- Familiarity with engineering documentation in a regulated setting.
- Technical writing or documentation review experience.
Alphanumeric is a dynamic company born of a diverse mindset and held to a distinctly high standard. You may know us as a tech and communications firm established in 1979, but we also lead life science and healthcare organizations toward a more efficient future across the globe, bringing patients and providers together to build personalized relationships that fit their needs.But at our core, we are a family with a shared and passionate dedication to our customers. We treat our candidates as amazing (because they are!)Apply today to join our family and Make Your Mark!
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.
