QC Microbiology Analyst

Job Description:Primary responsibilities for this position include performing tasks associated with critical testing on raw materials, environment, utilities, validation samples, and manufactured materials. The analyst will be responsible for ensuring that CSL Seqirus QC Microbiology 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.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.Develops and maintains SOPsDevelops expertise in assigned assays/techniquesAuthors lab investigation and invalid assay assessmentsMay be required to perform shift work as required to support the operationsIdeal Background Education Bachelor’s degree in Scientific discipline and 3+ years’ experience or associate’s and 5+ years of industry experience or equivalent3+ years of laboratory experience OR equivalent preferred.Intermediate knowledge of GMPs, safety regulations and data integrityIntermediate knowledge of analytical methods and related instrumentation.LIMS experience preferredExperience performing Environmental Monitoring within a pharmaceutical environmentExperience performing Bioburden, Endotoxin, and Sterility.Minimum Requirements (Must Have):BS/BA in Biology or Microbiology or other related science fieldExperience with environmental monitoring in manufacturing areasSome experience with working in an analytical testing lab (academic or industry)Desired Requirements (Nice to Have):Experience working in a cGMP Pharmaceutical LaboratoryExperience with Laboratory Information Management Systems (LIMS)Experience performing Bioburden, Endotoxin, and Sterility