Quality Control

5 days ago

Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time

Position OverviewSummary: The QC Stability Coordinator II will construct, maintain, and oversee the Quality Control Testing of Stability programs to include developing a schedule of pull dates, overseeing testing of each pull, and generating summaries from the data.The Quality Control Coordinator II, under general direction, will be responsible for implementing a Quality Control Stability Program that will encompass the needs of the client for each program.
The position will require frequent communication with the Chemistry, Cell Biology, Microbiology, and Quality Assurance groups to coordinate execution of testing, deviation management, and issuance of deliverables.
The Coordinator will have visibility to method qualification to ensure timing of stability laydowns.
Close attention to detail is required to oversee and compile the stability testing and data, to facilitate meeting deadlines and milestones.
Other responsibilities may include but are not limited to: ownership of CAPA's and deviations, client meetings, attending planning meetings, communication of changes, and utilizing new software.Company OverviewThe work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us.
We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives.
Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe.
We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FUJIFILM Diosynth Biotechnologies call Genki.Job DescriptionEssential Functions:Assists in preparing QC metrics on a monthly basisPerforming pulls occur within the specified windowEnsuring testing occurs within the specified windowAssist in generating POs for external testingWork directly with Contract laboratories to coordinate and monitor testing and release schedulesWork directly with customers to update and confirm schedules and deadlinesAttend daily briefings and update as neededAssist QC Director and QC ManagersAbility to work cross functionally with other Quality Control groups, Quality Assurance, Manufacturing, and Project Management to establish timelinesEstablish GMP documentationReview GMP documentationUpdate GMP documentationFollow all established laboratory, regulatory, safety, and environmental proceduresMaintain and execute a minimum of 8 stability protocolsProvide technical suggestions to customers based on industry guidelinesPerform other duties as assignedRequired Skills & Abilities:Extensive knowledge of stability testing protocols, methodologies, and regulatory requirementsUnderstanding of ICH guidelines for stability testingUnderstanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP).Must be highly organized, driven, and possess the skills and capability to plan ahead and stay on scheduleAbility to evolve and adapt to new technologies to include electronic planning tools and Laboratory Information Management Systems (LIMS)Computer skills in Microsoft Office and Microsoft ProjectAbility to multi-task and prioritize work assignments with little supervisionExcellent attention to detailAbility to work in a team or independent setting and collaborate with employees from various departmentsExcellent analytical and planning skillsMust have excellent organizational, written and oral communication skillsMinimum Qualifications:Bachelor's degree in chemistry, Biochemistry, Biology, Biotechnology, Microbiology or similar education and minimum of 2 years' experience between coordinator/management position and 1 year in a GxP setting; ORMaster's degree and minimum of 1 year experience between coordinator/management position and 1 year in a GxP setting.Preferred Qualifications:PMP CertificateKnowledge and experience with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)Analytical backgroundClient relations backgroundWorking Conditions & Physical Requirements:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to:Experience prolonged standing, some bending, stooping, and stretchingUse hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is requiredAbility to sit for long periods to work on a computerAttendance is mandatory
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