Specialist I/II/III, QA (Front Line) 2nd Shift at Seqirus in holly springs, North Carolina

Posted in Other 21 days ago.





Job Description:

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.

Job Purpose:

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


  • Hours: 2pm-12pm


  • Level will be determined based on years of experience



Major Accountabilities


  • 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.


Minimum Requirements:


  • Bachelors degree or equivalent industry experience.

  • Minimum 1+ year of experience; on the floor in Bulk/Fill Finish/Packaging pharmaceutical operations with technical understanding of the production processes used in the pharmaceutical or biotechnology industry preferred.

  • Previous experience in a GMP fermentation, purification, sterile formulation, sterile filling, or packaging operation preferred.

  • Previous experience in quality role in an FDA regulated manufacturing or laboratory setting preferred.

  • Strong organizational skills and ability to manage multiple tasks at one time.

  • Ability to follow assignments through to completion within defined timelines.

  • Strong communication skills, both written and oral.

  • Demonstrates risk based decision making.

  • Experience in root cause analysis, including working experience of root cause analysis tools such as fishbone/5Why preferred.