In this role, you will monitor and control the daily activities of quality inspections of incoming, in-process, final, and batch record review and release. You will manage the Quality Control team to ensure inspection process is executed in a proper and timely manner by ensuring procedures are followed and improved as part of a continuous improvement mindset
Essential Duties and Responsibilities
- Provides direct supervision, resolves personnel issues, conducts performance evaluations, and performs managerial discipline, as necessary
- Direct reports include quality control supervisors
- Leads and directs the Incoming Inspection, In-Process Inspection, and Batch Release teams with a positive and patient attitude
- Maintains and instills in others a “quality at the source” mentality as it pertains to all aspects of manufacturing, including documentation, training, and other functions related to production
- Maintains and instills in others an “immediate audit readiness” mentality so that records and actions are executed in a way that ensures their accuracy, legibility, and immediate retrievability
- Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations
- Schedule and prioritize quality inspection, testing, and batch record review and release to support Operations and release of product
- Identifies and develops opportunities to improve existing processes and procedures
- Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience
- Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence
- Manage the verbal communications and visual checks of work activity to ensure quality requirements are met. Ensure proper corrective actions, discrepancy reports and follow up activities are accomplished
- Reviews documentation and records for accuracy. Determines if product is impacted, can be released, or if Non‐Conformance Report is required
- Manages the development of documentation and procedures during the qualification of new equipment/inspection methods
- Creates, prepares, implements and improves Quality Control KPIs metrics
- Determines/sets Goals & Objectives for the Quality control organization and training programs for team's development purposes
- Supports investigations related to Non conformances, Audit observations, CAPAs, or Issue Reviews as needed
- Ensures equipment is up to date on Preventive maintenance and calibration activities
- Maintains the lab/area well organized with a 5S mindset
