Senior Quality Engineer

This is an onsite position requiring the team member to be onsite for all scheduled workdays.

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

• Provide end-to-end partnering to provide quality oversight to ensure alignment with stakeholders, customers and patient expectations

• Manage quality system platforms (Out of specifications (OOS), deviations, change control, Corrective and Preventive Actions (CAPA) and/or Document Control)

• Lead / participate in safety & quality enhancement initiative to drive continuous improvements within and across departments

• Promote quality culture and culture of continuous improvement

Essential Duties and Responsibilities

• Ensure that all products and processes adhere to both internal and external quality standards, including regulatory requirements

• Lead and contribute to safety and quality improvement initiatives aligned with plant KPI and objectives

• Lead QA department meetings to drive on-time tasks deliverables

• Manage quality platforms (Out of specifications (OOS), deviations, change control, Corrective and Preventive Actions (CAPA) and/or Document Control) ensuring alignment with plant KPI and objectives

• Provide end-to-end partnering to provide quality oversight, collaborating with assigned departments to address internal non-conformance promptly while meeting delivery targets

• Oversight of OOS, deviations, change control and validations to ensure compliance and timely closure

• Provide guidance to batch tracing and batch disposition

• Participate in A3s, providing quality guidance to root cause analysis, effective CAPAs

• Provide training on GMP-related topics

• Involve in CAPA management, compliance and timely closure

• On time review and approval of documentation and procedures

• Monitor, assess and improve quality programs to support operational excellence and compliance

• Compile and analyze monthly quality metrics, highlighting trends and areas for improvement

• Provide guidance and training to QA Engineers & Junior QA Engineers and/or other team members on quality-related processes and practices

• Lead and participate in internal and shop floor audits, ensuring compliance with quality standards

• Support and contribute to Lean Sigma program and activities towards delivery of the set target

• Assist the QA Manager in ensuring compliance with the ISO 15378 / 9001 requirements

• Maintain accurate and comprehensive quality records and reports to support compliance, audits and continuous improvement processes

• Other duties as assigned by the superior

Education

• Bachelor's Degree In Engineering or Science required

Work Experience

• Proficient in computer applications, particularly Microsoft Office

• Preferably 5-8 years' work experience in QA related activities

• Familiarity with SAP, cGMP, Lean principles, Power BI and/or ISO standards is advantageous

• Preferably with exposure to medical device, pharmaceutical or related manufacturing environment

Preferred Knowledge, Skills and Abilities

• Comprehensive understanding of relevant standard operating procedures in accordance with company policy related to the position covered by this Job Description

• Contribute to Lean Sigma initiatives and activities aimed at achieving set targets, minimize waste, and promoting efficient work execution

• Adherent to the company’s safety policy consistently

• Ensure use of Personal Protective Equipment (PPE) in respective work environments for all members

• Report unsafe conditions or acts to responsible personnel for corrections and improvements.

• Always commit to the company’s quality policy

• Ensure gowning procedures are followed at work environments for all members

• Lead monitoring / improvement activities to enhance operational support activities

• Participate in establishment and maintenance of documented procedure

• Good knowledge of cGMP requirement and strong quality mindset

Additional Requirements

• Manufacturing environment

• 20/30 Vision minimum, at near and/or far with at least one eye with or without corrective lenses and no color deficiency

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 Apply.Accommodation@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.