At West, we're a dedicated team that is connected by a purpose to improve patient lives. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun.
Requirements
- Support in maintaining compliance with cGMP standards within the laboratories.
- Provide GMP support for activities such as method validation, method transfer, instrument qualification, and verification of compendial test methods.
- Perform data audits and periodic reviews of laboratory test results, electronic raw data, laboratory notebooks, computerized systems, and Excel spreadsheets to ensure compliance and data integrity.
- Oversee proper administration and timely completion of cGMP processes, including On-time review of procedures
- Provide training on GMP-related topics
- Manage the Change Control process, including reviewing and processing change requests within SAP, monitoring and reporting change control trends, and supporting product disposition decisions to ensure compliance and risk mitigation.
- Manage the product monitoring activities, including planning review and statistical trending of test data, ensuring timely review and documentation.
- Conduct GMP orientation training for new employees to ensure awareness of quality and compliance requirements.
- Prepare and analyze Quality System metrics related to change control and data integrity, ensuring timely reporting.
- Support technology transfer projects to ensure quality requirements are defined and implemented effectively, if required.
- Lead and/or participate in product quality and quality system improvement initiatives.
- Lead and/or participate in contamination control strategy initiatives and shopfloor audits.
- Support and contribute to Lean Sigma programs and activities towards delivery of the set target
- Perform any other duties as assigned by the QA Manager
Benefits
- Empowerment of the physical, mental, emotional, and financial health of team members and their families
- Lifelong learning, growth, and development opportunities
- Inclusive community of professionals
- Diversity and equal opportunities employer
- Background screening contingent upon offer of employment
