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SUMMARY This position will be responsible for activities involving compliance with applicable regulatory requirements and internal policies within the Manufacturing Group. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.  Performs the compliance review and approval of all manufacturing batch documentation related to disposition of clinical products  Author/Review deviations and investigations  Writing/Reviewing Standard Operating Procedures for manufacturing department  Review Master Production Records  Performing routine internal audits of Manufacturing processes  Write and review protocols for development reports, IQ/OQ’s and validations  Follows Good Manufacturing Practices (GMPs), Standard Operating Procedures (SOPs)  Other duties as assigned or determined ...