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In this role, the Quality Project Manager will support the standardization of QMS process and data management across the organization. This position will lead the development and deployment of quality maturity, QMS improvements and quality cost related measures, evaluations, performance, and initiatives. This position will coordinate activities associated with quality maturity including continuous improvement projects relating to sustaining engineering activities, development of new methods/processes for product evaluation and product development activities through a standardized approach. In addition, this position will deploy highly capable, predictive, effective, and efficient quality cost metrics for West Pharmaceuticals. This position will also be responsible for leading and executing cost improvement initiatives, follow up assessments and action oversight.
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Responsible for providing expertise in Quality Assurance processes related to the manufacture of West products. Ensure compliance with regulatory requirements and West procedures. Proactively develop, lead, and drive the execution of the Quality Assurance strategy. Develop and implement quality assurance plans ensuring compliance with regulations, oversee interactions with regulatory agencies and build strong relationships with internal and external stakeholders. Champion advocacy for product, process, and system quality, and drive continuous improvement within the Quality Management System.
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Training for this position will take place Monday through Friday, following an 8-hour day shift schedule, until the second quarter of 2026. After that, the schedule will transition to a 12-hour night shift on a 2-2-3-2 rotation, running from 5:45 PM to 6:00 AM.
In this role, you will be responsible for performing highly diversified duties to install, troubleshoot, repair and maintain production equipment according to safety, predictive, and productive maintenance systems and processes to support the achievement of the site’s business goals and objectives.
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This Full-time onsite role will be supervising, coordinating and administering the site Quality Control systems compliance: Document Control, Nonconformance/ Deviation Reports, OOS Process, Measurement Systems, Change Control, Calibration and CAPA’s. Supervise and support internal projects and ensure cGMP compliance, applicable ISO requirements, company policies and procedures.
1st Shift Position, with occasional adjustments to accomodate 2nd/3rd shift interactions
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In this role you will be responsible for performing Supplier Quality activities associated with external suppliers. This role performs activities to ensure West supplier’s maintain compliance with West’s procedures and policies. You will interface with R&D, Sourcing, Design Quality, Regulatory and Operations Quality to drive improved supplier quality performance.
Establish and successfully executesupplier management planswhich will align to overall business objectives
Maintain a strong collaborativepartnership
supplier performanceincluding incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action Reports (SCARs)
ExecuteSupplier Corrective Action Requests(SCAR) with suppliers, ensuring effective and timely closure
Work with suppliers, R&D, and Sourcing on continuous improvement of supplier performance includingsupplier changerequest.
Evaluate potential new or future suppliers and support supplierselection processwith the cross-functional team
Participate in cross-functional teams of design engineering and quality engineering to work with suppliers duringproduct developmentand ensures agreement for manufacturable, cost-effective designs
Approves components for use in products by drivingProduct Approvalactivities with the suppliers
Supports Supplier evaluation,auditmanagement and related records
Supports the evaluation and development ofQuality Agreements and purchasing specificationswith suppliers
Support the development of anIncoming Inspection strategyon purchased products
Minimum 5 years of quality related experience with preferred experience in pharmaceutical and/or medical device industry
Experience working with suppliers and supplier engagement activities
Knowledge of sterilization process is preferred
Knowledge of cGMP, cGDP, relevant ISO standards, medical device requirements and other international regulations
Familiarity with MasterControl, SAP and working knowledge of statistical data analysis
Fluent in English
Thorough understanding of validation activities and risk management principles and techniques
Strong problem-solving and critical thinking skills
Negotiation skills and collaborating with suppliers
Ability to work under high volume production and fast changing environment
Willingness to work in a cross-functional team with different time zones
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In this role, you will be a customer focused individual responsible for completing preventative maintenance as scheduled, on injection molds. Analytical and excellent trouble shooting skills along with a drive for continuous improvement. Interpret part prints and/or mold prints to complete quality repairs to molds and secondary equipment. Perform polishing work, operate tool room equipment, surface grinders, Bridgeport milling machines, lathes, cutter grinders and sinker EDM.
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As the Global Equipment Compounding & Dimensioning Subject Matter Expert (SME) Leader, you will set the strategic direction and lead a team responsible for specifying, implementing, and improving equipment for weighing, mixing, and dimensioning processes in our global elastomer production facilities. You will cultivate a collaborative environment, align with cross-functional engineering teams, and drive our company’s vision for innovation and standardization in equipment processes.
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In this role, the Quality Project Manager will support the standardization of QMS process and data management across the organization. This position will lead the development and deployment of quality maturity, QMS improvements and quality cost related measures, evaluations, performance, and initiatives. This position will coordinate activities associated with quality maturity including continuous improvement projects relating to sustaining engineering activities, development of new methods/processes for product evaluation and product development activities through a standardized approach. In addition, this position will deploy highly capable, predictive, effective, and efficient quality cost metrics for West Pharmaceuticals. This position will also be responsible for leading and executing cost improvement initiatives, follow up assessments and action oversight.
These jobs might be a good fit