Analyst I, II,III QC (Microbiology)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Sep 12, 2020
Ref
R-120267
Required Education
Bachelors Degree
Position Type
Full time
About CSL

With operations in 35+ nations and ~ 22,000 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 the second largest influenza vaccine company 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

  • Schedule: Sunday- Wednesday
  • Hours: 7am- 5PM
  • (10 hour shifts/4 days per week)
  • Level will be selected based on years of experience


Major Accountabilities
  • Performs testing and associated tasks without errors per applicable SOPs and protocols.
  • Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.
  • Participates in lean lab operation, preventive action & continuous improvement programs to reduce operating costs
  • Performs shift-work as necessary to support manufacturing Participates and performs in cross-training to support staff availability within QC department
  • Develops and maintains SOPs
  • Develops expertise in assigned assays/techniques
  • Authors deviation and invalid assay assessments
  • May be required to perform shift work as required to support operations


Qualifications:

Bachelor's degree in Scientific discipline and 3+ years' experience or associate's and 5+ years of industry experience or equivalent
  • 3+ years of laboratory experience OR equivalent
  • Intermediate knowledge of GMPs, safety regulations and data integrity
  • Intermediate knowledge of analytical methods and related instrumentation.
  • LIMS experience preferred
  • Prefer experience with sterility testing (within an isolator), EM, water and clean steam collection, and gas sampling.
  • Method verification/validation experience (sterility, endotoxin, bioburden, and AET) preferred
  • Other technical competencies: Bioburden testing (membrane filtration), endotoxin testing (preferably Kinetic method), growth promotion testing of microbiological media, identification of microbiological isolates, and EM trending


Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.