Analyst I/II/III, QC (Environmental Monitoring/Microbiology)

Company: CSL Behring
Location: Holly Springs
Posted on: May 14, 2022

Job Description:

Job DescriptionJob Purpose: Primary responsibilities for this position include performing tasks associated with release testing and reviewing laboratory data. 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 role is on day shift - Wednesday- Saturday 4 (10) hour days Level will be determined 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, 6S laboratory layout, 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 operationsMinimum Qualifications:
  • Bachelors degree or Associate's degree and 3+ years of industry experience or equivalent.
  • Bachelors degree in Microbiology preferred.
  • Minimum of 1 year of laboratory experience OR equivalent.
  • Knowledge of GMPs, safety regulations and data integrity preferred.
  • Knowledge of analytical methods and related instrumentation.
  • LIMS experience preferred.
  • Prefer experience with sterility testing, EM, water and clean steam collection, and gas sampling.
  • Method verification/validation experience (sterility, endotoxin, bioburden, and AET) preferred.
  • Other technical competencies: Bioburden testing, endotoxin testing (preferably Kinetic method), growth promotion testing of microbiological media, identification of microbiological isolates, antimicrobial effectiveness testing (AET) and EM trendingAbout UsOur BenefitsSeqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.About SeqirusSeqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus .We want Seqirus to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.Do work that matters at Seqirus!

Keywords: CSL Behring, Cary , Analyst I/II/III, QC (Environmental Monitoring/Microbiology), Professions , Holly Springs, North Carolina