Review equipment calibration, validation, and maintenance records. Escalate and initiate product quality investigations Maintain department ISO documents and support of site initiatives through internal audit programs, quality investigations, and product performance reviews Manage Quality Control team and compliance activities to achieve key site and corporate objectives Effective verbal and written communication with team members and other departments of the organization Ability to successfully work on cross-functional basis with other site supervisors Minor Job Duties: Familiarity with writing product transfer and USP/vendors’ method verification protocols and reports Ability to write effective out-of-specification (OOS) investigation and out-of-trend (OOT) reports Collaborate and work effectively within the Quality Control groups other departments Represent the quality control department and departmental functions on company projects/committees Maintain and store complete and accurate QC records
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