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Role = QA Operations Specialist
Duration = Six months from start date, with possible 6-month extension
Standard Day Shift (Mon-Fri; 40 hrs/wk; 8 hrs/day)
Overtime or Weekends = Not required, but candidates should be open to it, if necessary
100% onsite work
The QA Operations Specialist provides a link between operations and the various quality systems. Primary responsibility is to directly support Operations through real-time, on-line batch record QA review and approval.
• 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
• Demonstrated familiarity and compliance with cGMP's, EHS procedures and regulations, facility regulatory guidelines, and standard operating procedures.
• Provide on the floor QA support and perform QA Operations activities (batch record review and issuance, line clearance, logbook and documentation review, aseptic processing oversight, 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 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.
• Provide QA review and approval for Validation documents, PQRs and Change Controls.
• BS/BA in biology, chemical engineering, life sciences. Degree in other discipline if sufficient technical depth has been achieved from profressional experience.
• Minimum of 3 years pharmaceutical experience in Quality Assurance preferrably in Biologics, Secondary Manufacturing or 3 years as a manufacturing technician in a Biologics Secondary Manufacturing operation.
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.