Quality Assurance Expert 2

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.

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:

• 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.

Minimum Qualifications:

• Bachelor's Degree in Chemistry, Biology, or other Life Science Discipline.
• 5+ years of experience in an ISO environment.

Preferred Qualifications:

• 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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