Description
Home Search Jobs Job Description Documentation Specialist Contract: Austin, Texas, US Salary: $32.00 Per Hour Job Code: 354238 End Date: 2024-10-24 Days Left: 20 hours left Apply We are seeking a highly detail-oriented Documentation Specialist 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. The specialist will perform in-depth batch reviews and approve quality documentation, ensuring compliance with regulatory and procedural requirements.
Key Responsibilities: - Batch Review: Conduct thorough documentation reviews, including Batch Records and Device History Records, ensuring accuracy and compliance with established procedures.
- Quality Document Approvals: Approve quality documents in line with the company's regulatory standards.
- Non-Conformance Management: Identify and escalate non-conformances as necessary, adhering to the company's escalation protocols.
- CAPA: Support Corrective and Preventative Actions (CAPA) when applicable.
- Compliance: Follow strict procedures and regulatory requirements, identifying document discrepancies and escalating as needed.
- Collaboration: Work closely with cross-functional teams to ensure alignment with quality standards.
Qualifications: - Education: Bachelor's degree (preferably in STEM fields such as Engineering or Science).
- Experience:
- 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.
- Attention to Detail: Must demonstrate excellent attention to detail and the ability to follow complex procedures accurately.
- Regulatory Knowledge: Strong understanding of medical device quality documentation and compliance with industry standards.
- Documentation Expertise: Must know how to review and determine the adequacy of quality documents, escalating issues when necessary.
Top 3 Skills: Ability to meticulously follow procedures. Strong attention to detail in document review and compliance. In-depth understanding of medical device quality documentation. Job Requirement - Documentation
- CAPA
- Non-conformance
- Batch Review
- Quality Document Approvals
- Compliance
- Medical Device
- FDA
- ISO
Reach Out to a Recruiter - Recruiter
- Email
- Phone
- Gagandeep Singh
- ...@collabera.com
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