Quality Assurance Expert II

Job Description

Duties and 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.