6 jobs found in holly springs

Job Purpose:  Responsible for providing quality system support to Fill Finish manufacturing areas within the Seqirus Vaccines manufacturing facility located in Holly Springs, NC. Responsible for Deviations and investigations using Root Cause analysis and technical writing to complete reports for audit purposes. *Level will be determined by years of experience Major Accountabilities: Owns deviations and writes product impact assessments. Leads cross functional investigation teams in root cause analysis Creates and executes CAPA plans to reduce the likelihood of reoccurrence. Writes SOPs and batch records to support expansion activities Issues SOPs and Batch Records to the production floor Owns change controls including site wide change controls. Writes Biological Product Deviation Report for submission to the FDA. Performs Product Technical Compliant and Adverse Event investigations. Provides technical support with multiple unit operations. Identifies...

Job Purpose:  Responsible for providing quality system support to Bulk manufacturing areas within the Seqirus Vaccines manufacturing facility located in Holly Springs, NC. Responsible for Deviations and investigations using Root Cause analysis and technical writing to complete reports for audit purposes. *Level will be determined by years of experience Major Accountabilities: Owns deviations and writes product impact assessments. Leads cross functional investigation teams in root cause analysis Creates and executes CAPA plans to reduce the likelihood of reoccurrence. Writes SOPs and batch records to support expansion activities Issues SOPs and Batch Records to the production floor Owns change controls including site wide change controls. Writes Biological Product Deviation Report for submission to the FDA. Performs Product Technical Compliant and Adverse Event investigations. Provides technical support with multiple unit operations. Identifies solutions to...

Job Purpose: You will report to the Sr. Manager of Manufacturing. You will be responsible for production shop floor supervision for the night shift in a Flu Vaccine manufacturing facility. You will manage the Fill and Finish area that includes packaging, labeling, and inspection of finished drug products for us. You will coach, mentor, and train a team of up to 18 people. Night Shift Hours: 6pm-6am Schedule: 2,2,3 with every other weekend off Responsibilities: You will: Supervises a staff of shift production personnel to ensure safety, training and quality compliance are prioritized for manufacturing goals for us. Development and performance management of manufacturing staff Manages resources and material requirements to meet production and budget targets with us. Responsible for content and correct execution of SOPs and production batch records Responsible for deviation investigations and technical problem solving Support continuous improvement...

The Opportunity In this role, you will report to the Manager, Direct Analytics & Process Monitoring, and be part of the Manufacturing Sciences & Technology team at the Holly Springs Influenza Vaccine manufacturing facility, supporting Bulk and Fill Finish Operations. The MS&T function provides strategic technical direction to manufacturing organizations (including 3rd parties) to achieve supply targets and maximize capacity. You will have responsibilities including providing analytical expertise related to the collection, assessment, comparison, and interpretation of data sets derived from manufacturing. The Role Use your experience with statistics in biopharmaceutical processes to provide technical leadership in the performance of complex statistical analysis required for: Regression analyses OOS / OOT / OOL / Deviation Investigations Process comparability design and analysis Process Improvement Capability Assessment Use a structured...

Overview The work we do at FDB 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 manufacture 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 we call Genki. We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America. The new site will offer end-to-end solutions   to our customers looking...

Overview The work we do at FDB 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 manufacture 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 we call Genki. Join us We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America. The new site will offer end-to-end solutions   to our...