Specialist I/II/III, QA (Front Line) 2nd Shift

CSL Behring
Holly Springs, North Carolina
Mar 07, 2021
Required Education
Bachelors Degree
Position Type
Full time
About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

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-12am
  • 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.