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At West, we're a dedicated team connected by a purpose to improve patient lives, which has been central to our company for over 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 II. Through our efforts to deliver thousands of life-saving and life-enhancing injectable medicines to millions daily, West's impact on healthcare is just beginning. 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 our communities and are committed to creating a healthier environment through our sustainability efforts.
Job Summary
This global role supports Quality Systems functions, including audit, document control, change control, notifications, training/LMS, CAPA, and specifications. The role ensures compliance with West Quality Management System procedures, protocols, regulations, and standards. You will drive quality system improvements across West.
Essential Duties and Responsibilities
- Maintain records to demonstrate compliance with regulations and company policies.
- Use MasterControl as an administrator/Sub-Admin/SME.
Capture and analyze metrics, report performance to management, support cross-functional quality improvement projects, change management, CAPA, specification management, and training.
Support and guide internal and external customers on QMS-related requests and questions.
Assist with corporate harmonization initiatives related to QMS.
Identify initiatives to improve system effectiveness and efficiency.
Participate in internal and external quality audits as part of the team or in a supporting role.
Work independently with moderate guidance.
Other duties as assigned.
Additional Responsibilities
Education
- Bachelor's Degree in science or related discipline preferred or equivalent experience required.
Work Experience
- Minimum 3 years of quality-related experience, preferably in the medical device or pharmaceutical industry.
- Experience with SAP and MasterControl preferred.
Knowledge, Skills, and Abilities
- In-depth knowledge of cGMP, cGDP, 21CFR820, ISO standards (9001, 15378, 13485).
- Familiarity with electronic document management systems, especially MasterControl.
- Compliance with safety and quality policies at all times.
License and Certifications
Travel Requirements
Up to 13 business days per year (5%).
Physical Requirements
Sedentary work involving occasional exertion up to 10 lbs/4 kg.
Additional Requirements
- Excellent communication and interpersonal skills.
- Strong organizational skills for planning and goal achievement.
- Ability to analyze situations, identify solutions, and solve problems with moderate guidance.
- Ability to work well with others across organizational levels.
- Multi-tasking and working under time constraints.
- Independent judgment and protocol adherence.
West is an equal opportunity employer valuing diversity. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability. For accommodations, contact Apply.Accommodation@westpharma.com. Employment offers are contingent on background and drug screening where permitted by law.
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