Documentation Specialist
3 days ago
We are seeking a highly detail-oriented individual to support third-party medical device operations, focusing primarily on Batch Records and Device History Records (DHRs). The role is onsite in Austin, TX, and requires experience in regulated environments such as medical devices or pharmaceutical manufacturing.
Key Responsibilities:- Conduct thorough documentation reviews, including Batch Records and Device History Records, ensuring accuracy and compliance with established procedures.
- Approve quality documents in line with the company's regulatory standards.
- Identify and escalate non-conformances as necessary, adhering to the company's escalation protocols.
- Support Corrective and Preventative Actions (CAPA) when applicable.
- Follow strict procedures and regulatory requirements, identifying document discrepancies and escalating as needed.
- Bachelor's degree (preferably in STEM fields such as Engineering or Science).
- Minimum 3 years of experience in a medical device or pharmaceutical regulated environment (manufacturing preferred).
- Hands-on experience with documentation, quality document reviews, batch releases, or lab notebook processes (in design, manufacturing, or release phases).
- Exposure to non-conformance handling and CAPA processes is a plus.
- Ability to meticulously follow procedures.
- Strong attention to detail in document review and compliance.
- In-depth understanding of medical device quality documentation.
Job Requirements: Documentation, CAPA, Non-conformance, Batch Review, Quality Document Approvals, Compliance, Medical Device, FDA, ISO
Reach Out to a Recruiter: Gagandeep Singh
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