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Title:  QA Manager

Requisition ID:  36126
Date:  Jun 21, 2022
Location: 

Kearney, Nebraska, US

Department:  Quality
Description: 

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:

Assure compliance of the plant processes and products to established industry standards, specifications, and procedures, ensure quality system is implemented and its integrity maintained.

 

Essential Duties and Responsibilities:

  • Directs and manages quality control, quality systems, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output as possible.
  • Manage and maintain an effective Quality Assurance program for the plant in alignment with Global Operating Procedures and capable of maintaining ISO 9001 and 15378 certification status.
  • Review operating procedures to ensure compliance with all related procedures, instructions and the Quality Manual.
  • Establish procedures and methods to comply with applicable GMP, ISO requirements and customer expectations
  • Ensures timely resolution to customer inquiries (audit findings and complaints)
  • Review customer requirements and make sure the system is in place to meet them
  • Investigate and ensure implementation of the corrective actions associated with non-conformances, including, customer audits and complaint reports
  • Achieves quality operational objectives by contributing information and analysis to strategic plans and reviews.
  • Conduct routine quality project management reviews with project Teams and management
  • Drive continuous quality improvement projects at plant based on site data and customer expectations
  • Drive compliance to global harmonization initiatives
  • Conduct plant Quality Management Review meetings of the plant quality system
  • Establish and monitor plant Quality Metrics used to evaluate the effectiveness of the Quality System
  • Manage Quality Staff at site to assure knowledge and execution of site Quality System
  • Assure proper use of change management associated with validated processes
  • Assure execution of internal audit program
  • Adjust in process/final sampling plans & related accept/reject criteria to ensure compliance to specification and customer requirements
  • Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness
  • Drive continuous quality improvement projects and global harmonization initiatives
  • Utilize PMI strategies and techniques to manage Scope, Time, and Budget.
  • Maintain clear communication paths with stakeholders
  • Identifies and determines quality improvement
  • Maintain clear communication paths with stakeholders
  • Performs other duties as assigned based on business needs

 

Basic Qualifications: 

  • Education: Bachelor's in...Science or Engineering, or commensurate experience
  • Experience: 6-10 years of experience in...Quality Assurance / Quality Control / Quality System

 

Preferred Knowledge, Skills and Abilities:

  • Superior organizational and leadership skills with ability to help team grow and thrive
  • Experience with Customer interface and meeting customer expectations.
  • Demonstrate team building and problem-solving skills
  • Ability to effectively prioritize and escalate issues
  • Working familiarity with Project Management Tools and Quality Risk Management.
  • Working knowledge of ISO requirements (15378) and Pharmaceutical Industry requirements (cGMP, etc)
  • Able to comply with the company’s safety policy at all times
  • Able to comply with the company’s quality policy at all times

 

Travel Requirements:

  • Minimal Travel for customer interface

 

Physical & Mental Requirements:

  • Work in a manufacturing environment, subject to heat and cold as well as loud noise.
  • Work in an office environment.  At times must sit for extended periods of time.
  • Ability to effectively communicate and comprehend complex ideas and concepts.
  • Use written and oral communication skills.
  • Read and interpret data, information and documents.
  • Must maintain the ability to work well with others in a variety of situations.
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize.
  • Ability to make independent and sound judgments.
  • Observe and interpret situations, analyze and solve problems.
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description

 

 

 

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to kimberley.eby@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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