Quality Assurance Lead

At West, we're dedicated to improving patient lives. Our purpose has been at the center of our organization for over a century.

We began our journey when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work delivering life-saving and life-enhancing injectable medicines to millions of patients daily, we've made an indelible mark on the healthcare industry.

Sr Assoc, Quality Systems Job Summary

This role leads the coordination of Change Control activities, ensuring compliance with internal and external requirements. As the subject matter expert and administrator for change control documentation, you'll oversee the global Change Control process, leading review board activities and collaborating with cross-functional teams.

• Oversee the overall global Change Control process, leading change control review board activities (documentation, data, customer notifications and approvals, etc.)
• Collaborate with cross-functional teams on West change controls and provide guidance and quality consultation to change control owners on change levels and associated tasks
• Assist change owners in outlining action plans, tasks, and responsibilities to ensure timely execution of changes
• Drive visibility and oversight to changes across the network to ensure applicability and consistency
• Oversee assessment of change controls and assure change impact is considered across products, platforms, life cycle phases, supply chain, and processes
• Ensure change control information is accurately entered into the appropriate tracking database
• Provide mentoring and training to change owners on change control processes and tools
• Work with global, cross-functional groups, manufacturing sites, and customers as needed to determine compliance with customer specifications
• Monitor and communicate metrics and trend reports to management for the Change Control system as needed
• Collaborate on cross-functional teams in determining specification content
• Evaluate change control processes and tools to drive continuous improvement activities

Additional Responsibilities

Ensure adherence to corporate quality system requirements.

Education

Bachelor's Degree in Science or equivalent experience required; Master's Degree in Science or equivalent experience preferred.

Work Experience

Minimum 5 years of experience in regulated quality assurance/quality control required; experience with qualifications, quality risk management, quality systems such as ISO 13485, 21 CFR 820, ISO 14971, medical device product development life cycle activities, verification/validation activities, risk management, DHF activities, MasterControl, SAP, SharePoint, Teamcenter preferred.

Preferred Knowledge, Skills, and Abilities

Able to work independently, multitask, and thrive in a fast-paced environment. Excellent critical reading and writing skills. Must have effective problem-solving and interpersonal skills. Able to comply with the company's safety policy at all times. Knowledge of cGMP, cGDP.

License and Certifications

TBD.

Travel Requirements

Up to 13 business days per year.

Physical Requirements

Sedentary work involves sitting most of the time. Exerting up to 10lbs/4kgs 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.

Additional Requirements

Adaptable to changes in the work environment, manage competing demands, and deal with frequent change, delays, or unexpected events. Maintain the ability to work well with others in various situations. Make independent and sound judgments. Observe and interpret situations, analyze, and solve problems. Maintain high attention to detail, accuracy, and overall quality of work. Effectively communicate and interface with various levels internally and with customers.

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