Quality Assurance Expert 2
•Today
| Hours | Full-time |
|---|---|
| Location | Round Rock, Texas |
About this job
Job Description
Job Description
Job Title: Quality Assurance Expert 2
Job Location: Round Rock, TX
Job Duration: 12 months
Shift: Mon - Fri, 8:00am - 5:00pm CST
Key Responsibilities:
Job Location: Round Rock, TX
Job Duration: 12 months
Shift: Mon - Fri, 8:00am - 5:00pm CST
Key Responsibilities:
- Coordinate and perform review and approval of completed batch records, raw material records, validations, stability records, and other quality documents to ensure compliance with applicable procedures, test specifications and methods.
- Perform document record review and approval of batch records, equipment qualifications, calibration records, analytical methods, method validations, stability protocols, and other quality documents for completeness and accuracy.
- Generating and review Certificate of Analysis (CoA) for catalog and custom projects.
- Assist in preparation and hosting external audits including customer, ISO, and DEA audits.
- Generate quarterly metrics summarizing documentation review and production activities.
- Perform review and approval of Standard Operating Procedures to ensure compliance with regulatory and company quality requirements.
- Regularly communicate with the QA management any problems and concerns that may delay or lead to the failure of the completion of projects, qualifications, validations, or other quality documents.
- Assist with internal audits as needed to maintain audit schedule.
- Support rollout of local and corporate initiatives.
- Bachelor's Degree in Chemistry, Biology, or other Life Science Discipline.
- 5+ years of experience in an ISO environment.
- Working knowledge of quality system requirements of the pharmaceutical and/or clinical industries.
- Prior work experience in an ISO, or similarly regulated environment.
- Knowledge of ISO 9001, ISO 17025, ISO 17034 and ISO 14001.
- Strong technical knowledge base and the ability to comprehend and communicate basic technical concepts.
- Ability to communicate effectively with all levels within the organization and with outside contacts.
- Self-motivated with the ability to work independently.
- Ability to critically review documents for discrepancies with written procedures and requirements.
- Knowledge with Root Cause Analysis and experience with eQMS system Veeva or similar.
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Full-time Jobs Part-time Jobs Gig Jobs Posting ID: 1295560067 Posted: 2026-09-09 Job Title: Quality Assurance Expert
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