Manufacturing Quality Manager

 

Who We Are:

 

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

 

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

 

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

Job Summary

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. In his position, 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.
• Exhibits regular, reliable, punctual and predictable attendance.
• Creates, prepares, implements and improves Quality Control KPIs metrics.
• Determines/sets Goals and 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.
• Other duties as assigned.

Education

• Bachelor's Degree in Technical or Engineering or equivalent experience required

Work Experience

• Minimum 8 years in quality control required
• 3+ years of supervisory experience required

Preferred Knowledge, Skills and Abilities

• Metrology Equipment experience
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety and quality policies at all times

License and Certifications

• Certified Manager of Quality/Operational Excellence preferred

Additional Requirements

• Mu