QA Specialist - Level 1 US
• Perform technical review of cGMP documentation for completeness and compliance to cGMPs as outlined by governmental regulations and internal procedures.
• Provide advice and counsel on cGMP and related quality assurance issues to the value stream
• Demonstrate sound decision making relating to quality issues
• Provide on the floor QA support and perform QA Operations activities (batch record review and issuance, room release, line clearance, documentation review etc)
• Take initiative to resolve quality documentation concerns (e.g., investigations, deviations, change controls, and other required documentation).
• Perform review and support regarding discrepancies and/or anomalies noted during QA review of associated processes. This includes deviation investigations, customer complaint investigations, et al.
• Alert management of production trends which may serve as forewarning of process or equipment problems. As necessary, initiate CAPA investigations to address these issues.
• Write and/or revise controlled documents in support of job responsibilities.
• Routinely communicate and report deviations from procedures/processes to Quality Assurance Management and initiate appropriate action as necessary.
• Ensure all GMPs, validation, quality, safety and environmental regulations are met. Adhere to all GSK safety guidelines and procedures.
1. Minimum Level of Education*
• BS/BA in biology, chemical engineering, life sciences. Degree in other discipline if sufficient technical depth has been achieved from professional experience.
QA experience preferred. Minimum 1 year also preferred.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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