Manager, QC

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than 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 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. 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 the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.   Job Summary

In this role, you will lead the Quality Control team and provide end-to-end oversight of mold monitoring, incoming material control, in-process, semi-finished and finished goods inspection, and batch release activities. You will ensure QC operations are executed timely and in compliance with approved procedures, customer requirements, cGMP guidelines and applicable quality standards, while partnering closely with Production, Engineering, Supply Chain, Technology Transfer and Quality Assurance to drive investigations, technical support and continuous improvement. Essential Duties and Responsibilities

Manage the QC team comprising Associate Managers, Engineers, Team Leads and Technicians to ensure timely execution of mold monitoring, incoming material sampling and testing, and IPC, SFG and FG visual and dimensional inspections in compliance with approved procedures and cGMP requirements. Oversee incoming material and batch release activities to ensure only conforming materials and products are released based on approved specifications, inspection plans and supporting records. Review and approve inspection and testing results, product disposition decisions and quality records associated with raw materials, in-process products, semi-finished goods and finished goods. Provide technical ownership for raw material inquiries related to inspection plans and RMTS, ensuring requirements, methods and acceptance criteria are accurate, current and aligned with site and customer expectations. Create, review and revise product inspection plans through SAP and ensure changes are properly assessed, approved, implemented and communicated to relevant stakeholders. Support technology transfer activities, including risk assessment, equivalency studies, part number setup, validation support and readiness of QC inspection and release requirements for new or changed products. Review gamma irradiation certificates (if required) and Certificates of Analysis to confirm completeness, accuracy and compliance prior to product use or release. Prepare sample Certificates of Analysis in response to customer requests and coordinate required data with the relevant stakeholders in a timely manner. Manage low yield and rheology deviations by leading investigations, root cause analysis, product impact assessment and effective CAPA implementation. Manage quality issues arising from manufacturing processes, including deviations, OOS and non-conforming products, to ensure timely containment, investigation and resolution. Apply effective containment, segregation and bracketing decisions for rejected or suspect product to prevent unintended release of non-compliant materials or products. Trend rejection, yield, rheology, inspection and release data to identify recurring issues, assess performance and drive continuous improvement with Operations and cross-functional partners. Perform regular