QC Specialist NPI and Network Testing We are seeking to recruit a QC specialist who will work as part of the integrated QC NPI and Network Testing team.
The QC specialist will oversee and manage the site QC readiness activities associated with New product introductions and Testing performed on site in collaboration with our global stability team.
Key Responsibilities Lead QC NPI and network testing activities, including NPI demand planning across internal and external networks, cross-site coordination, and implementation of QC NPI requirements Collaboration with internal and external partners in a cross-functional environment to drive compliance and operational excellence for testing Coordination of testing activities performed across both internal and contract testing facilities, investigating out of specification/ out of trend results, and communication with integrated project teams for biologics, vaccines, and/or devices Ensure the Lab sample management and reporting procedures, together with associated systems (e.g GLIMS/ SAP) are maintained to Support NPI and Network testing requirements.
Execute deviations and investigations, Change Management records, manage GMP documentation including GLIMS updates, Standard Operating Procedures (SOP), and GMP data management.
Support authoring and approval of Annual Product Review Support document requirements for new product registrations and batch reallocations Assessment of network testing impact as a result of Pharmacopeia and Quality standard updates Qualifications and Experience 3-5 years experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes experience in a QC function.
Degree in Science, Engineering or similar Knowledge of c GMP in Laboratory Quality Systems.
Knowledge of laboratory testing regulatory requirements.
Demonstrated experience in Report, standards, policy writing.
Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
Good communication, interpersonal skills and ability to work across teams.
Has experience in elements of the lean toolkit including value stream and process mapping, standard work, tier process, problem solving, Leader Standard Work, 5 S work place organization, Strategic A3 thinking, Hoshin Kanri, managing change, 8 wastes identification, poka yoke and Kanban.
Proven decision-making capability with accountability and responsibility.
Skills: QC Quality Control NPI Network Testing Lab