Analyst I/II/III, QC (Chemistry)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Aug 27, 2020
Ref
R-113265
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

Primary responsibilities for this position include performing tasks associated with HPLC, UPLC, and GC testing for GMP release of raw materials and drug product. Secondary responsibilities include cross training of staff. The analyst will be responsible for ensuring that Seqirus samples are collected, tested, and reviewed according to quality requirements, and results reported are valid, accurate, and documented per applicable regulatory and corporate requirements. Analyst may be required to perform or participate in tasks associated with method validation and transfers. Major Accountabilities:
• Performs HPLC, UPLC, and GC testing for QC samples in a pharma/biotech
• Performs GMP testing and associated tasks without errors per applicable SOPs and protocols
• Acts as a subject matter expert for HPLC, UPLC, and GC testing
• 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, 6S laboratory layout, preventive action & continuous improvement programs to reduce operating costs
• 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
Job Purpose:

Primary responsibilities for this position include performing tasks associated with HPLC, UPLC, and GC testing for GMP release of raw materials and drug product. Secondary responsibilities include cross training of staff. The analyst will be responsible for ensuring that Seqirus samples are collected, tested, and reviewed according to quality requirements, and results reported are valid, accurate, and documented per applicable regulatory and corporate requirements. Analyst may be required to perform or participate in tasks associated with method validation and transfers.
  • This position follows the M-F/8hr shift.
  • Level will be selected based on years of experience.


Major Accountabilities:
  • Performs HPLC, UPLC, and GC testing for QC samples in a pharma/biotech
  • Performs GMP testing and associated tasks without errors per applicable SOPs and protocols
  • Acts as a subject matter expert for HPLC, UPLC, and GC testing
  • 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, 6S laboratory layout, preventive action & continuous improvement programs to reduce operating costs
  • 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


Minimum Requirements:
  • Bachelor's degree in Scientific discipline and 3+ years' chromatography experience or Associates degree and 8+ years of industry experience or equivalent
  • In depth knowledge of HPLC, UPLC, and GC methods and instrumentation
  • Advanced knowledge of GMPs, safety regulations and data integrity. GMP experience in a pharma/biotech environment is a must
  • Intermediate knowledge of other analytical methods and related instrumentation.
  • LIMS experience is a must
  • Empower experience is a must
  • Method development and method verification/validation experience preferred
  • Other technical competencies: UV/Vis, Karl Fischer, Titrations, compendial raw material testing