Posted in Other 21 days ago.
Come join a company that tackles fascinating problems and find solutions to complex challenges. With deep expertise in influenza science, our team works on cutting-edge research, pioneering technologies to optimise the manufacturing process and improve the effectiveness of influenza vaccines. We operate as one integrated global organisation, drawing together expert staff from different countries to collaborate. Together, we are working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.
The Front Line Quality Assurance Specialist will provide on the floor support to manufacturing (bulk, sterile formulation/filling, and packaging), laboratories, utilities, maintenance, and logistics at the Holly Springs site. Core responsibilities of this role include quality walkthroughs on the floor, GMP record reviews and approvals, and real time triage of quality related issues.
Days: Tues - Fri
Level will be determined based on years of experience
QA oversight of manufacturing processes, QC laboratories, and in-process sampling.
QA oversight of control, quality systems, and QA compliance.
Review of standard operating procedures (SOPs), batch production records
Use of computerized systems: SAP, CMMS, TrackWise, GLIMS, Delta V, and BAS.
Utilize knowledge of root cause analysis and risk based decision-making throughout.
Collaborate with cross-functional teams while participating on projects.
Quality review of manufacturing, QC, warehouse, utilities, and facilities.
Review/approve BPRs', Log books, protocols and SOP's, ETP's (Engineering Test Plans.
Responsible for knowledge of current local and international regulatory requirements.
Provide advice and appropriate technical support on all quality/compliance matters.