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CAPA Specialist

West Pharmaceuticals

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Scottsdale, AZ
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Job Description

As posted by the hiring company

Job Overview:

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:
Supports all quality system and functions for the Kearney facility. Assists in establishing systems to support the facility to drive continuous improvements and minimize the costs of non-conformance. Plans, schedules, executes and communicates all items regarding quality issues, complaints, validations and other projects to the QA Manager and/or other interested parties. Performs all duties associated with compliance-related items for ISO standards and cGMps.

Essential Duties and Responsibilities:
• Participates in ISO and corporate quality system audits.
• Leads and assists in investigation of NCRs and CAPAs as necessary to identify and find the root cause of all product and related quality issues.
• Assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or validate facility products or processes, including development and implementation of any new or required inspection methods and in-process SPC programs.
• Assists facility with quality improvement programs by utilizing Six Sigma tools and Lean techniques, including the education of facility personnel on these tools and techniques.
• Maintains and reports information on statistics on facility quality performance, including Cost of Quality data.
• Organizes and leads CAPA Review Board meetings.
• Develops and implements best practices for root cause analysis and corrective action assignment and execution.
• Fills in for Quality Manager as requested or required.
• Promotes a culture of Quality First, Last, and Always throughout the organization.
• Performs other duties as required and/or assigned.

Basic Qualifications
• Bachelor degree
• Emphasis in science or engineering, or related experience

Travel Requirements:
• Must be able to travel up to 10% of the time

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 [email protected]. 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.