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In this global role, you will support Quality Systems functions which may include one or more of the following: Audit, global and local Document Control, Change Control and Notification, Training/LMS, CAPA, and Specifications. The role will ensure compliance to West Quality Management System procedures and protocols as well as applicable regulations and standards. In this global role, you will drive the improvement of quality systems across West.
Essential Duties and Responsibilities
* Maintain records and documentation to demonstrate compliance to regulations and company policies, procedures and requirements.
* Use MasterControl as an administrator/Sub-Admin/SME
* Capture and maintain metrics, including trending and analysis, on relevant processes and report performance to management.
* Engage with and support cross functional teams on quality improvement projects, change management, CAPA, specification management, training etc.
* Support and provide guidance to West’s internal and external customers as needed with QMS related requests and questions.
* Support corporate harmonization initiatives as they pertain to the quality management system.
* As appropriate, use knowledge and experience to identify initiatives to improve the effectiveness and/or efficiency of systems.
* Participate in quality audits (Internal and External) as needed either as part of audit team or supporting backroom activities.
* Ability to work independently with a moderate level of guidance and direction.
* Other duties as assigned.
Additional Responsibilities
Education
* Bachelor's Degree in science preferred or equivalent experience in related discipline required
Work Experience
* Minimum 3 years Quality related experience with preferred experience in Medical Device / pharmaceutical industry required
* Experience with SAP systems preferred
* Experience with MasterControl preferred
Preferred Knowledge, Skills and Abilities
* In-depth knowledge of cGMP, cGDP, 21CFR820, relevant ISO standards (9001, 15378, 13485)
* Familiarity with electronic document management databases, particularly MasterControl.
* Able to comply with the company’s safety policy at all times
* Able to comply with the company’s quality policy at all times
License and Certifications
Travel Requirements
5%: Up to 13 business days per year
Physical Requirements
Sedentary - Exerting up to 10 lbs/4 kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Additional Requirements
* Excellent oral and written communication and interpersonal skills
* Organizational skills that will enable planning, prioritization and achievement of goals
* Observe and interpret situations, analyze possible solutions, and solve problems with a moderate level of guidance
* Must maintain the ability to work well with others in a variety of situations and at varying organizational levels in the business
* Must be able to multi-task and work under time constraints
* Ability to make independent and sound judgments
* Ability to follow protocol
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