Scientist Development

Job description

Job Description

Responsibilities:

Position is in the QC Microbiology Lab/Environmental Monitoring (EM) Compliance Team

Collect, analyze, and report on EM data

Review all Micro/EM data

Complete GCC's with a change coordinator role and Document revisions

Support Audits

Supports studies and investigations as required to support testing or compliance issues

Represents laboratory on company cross-functional teams

Read EM plates and document results in logbooks and LIMS system

Subculture microbes for identification

Perform swabbing and sampling to support investigations

Gather and compile data from LIMS systems

Generate tables and graphs

Conduct Training

Perform QC assessments for Environmental, Bioburden and Utility Monitoring deviations

Perform trending on environmental and utilities monitoring results

Support Environmental and Utility Monitoring sampling as needed

Follows Standard Operating Procedures (SOPs) and maintains compliance to current Good Manufacturing Practice (cGMP) regulatory guidelines

Qualifications:

• Bachelors degree in a relevant scientific discipline or equivalent vocational or technical training

• 3-5 years' related pharmaceutical experience including experience in a regulated environment

• Knowledge of cGMP standards

• Proficiency in Microsoft Office and QC systems

•Strong analytical, quantitative, and problem-solving skills.

•Capacity to work independently and ability to prioritize tasks and meet deadlines.

Preferred Qualifications

Experience in environmental sampling/monitoring

Experience in analytical laboratory data review

Our Benefits

We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.