Analyst I/II/III, QC (Environmental Monitoring/Microbiology)
Company: CSL Behring
Location: Holly Springs
Posted on: May 14, 2022
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
- 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
- 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
- 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
- Knowledge of analytical methods and related
- 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
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