QA Documentation Specialist I
$80.33k - $103.95kGilead
Kite Pharma seeks a QA Documentation Specialist to manage document control processes, maintain GMP compliance documentation, and support quality systems. The role requires pharmaceutical industry experience and proficiency with electronic document management systems.
Responsibilities
- Implement change requests, document change orders, and ensure timely distribution of documents
- Maintain documentation manuals and verify accuracy of database entries
- Support GXP documentation distribution and conduct scanning, verification, and archival
- Provide training on electronic systems and support internal and regulatory audits
- Monitor document control metrics and recommend process improvements
Requirements
- 5+ years pharmaceutical industry experience with high school diploma
- 3+ years experience with associate degree
- Advanced knowledge of document control, quality systems, and GMP requirements
- Proficiency with Electronic Document Management Systems (EDMS)
- Strong Microsoft Office and Oracle proficiency
- Working knowledge of 21 CFR, GxP, ICH regulations
- Excellent attention to detail and written communication skills
Compensation: $80,325.00 - $103,950.00 base
Vacancy posted 2 days ago
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$80.33k - $103.95k
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