- Able to ascertain assay trend and instrument problems and communicates issues to the Supervisor or Instrument Specialists
- Assist in the review of trend charts.
- Independently perform the electronic document revision process.
- Assist in generating reports as deemed necessary by the Group Lead
- Represents team in Tier and departmental meeting and communicates between QC,QAO,
- Manufacturing depts., and Validation
- Ensures laboratory testing is performed in accordance with approved methods and SOP’s
- Fully proficient and knowledgeable in the designated testing area and methodologies. Can perform testing and troubleshooting without supervision.
- Ensures team responsibilities are completed during and before shift change. (i.e. Daily instrument checks, calibrations, assay review)
- Solicit information from group when revising OJT’s, SOP’s and Methods.
- Responsible for writing and reviewing laboratory OOX investigations; in that they are complete, concise and ready for management signatures.
- Identify and lead troubleshooting activities for equipment/testing issues.
- Competent to devise a plan to continue manufacturing support if issues cannot be resolved.
- Mentor new analyst and on-board them by demonstrating testing or sampling techniques along with frequently asked questions.
- Coaches and provides feedback to team members. Supports their on-going development. Provides input to group lead on Individual Performance Reviews of their team members.
- Responsible for ensuring inter- and cross-shift communication pertaining to manufacturing issues, instrument troubleshooting, and testing delays. Ensure communication to Group Lead.
- Ensure analysts complete accurate supply inventory.
- Ensure the work environment is safe and personnel adhere to safety procedures/policies. Real time reporting of EHS incidents or near misses.
- Real time communication between functional groups (manufacturing, validation, etc) in regards to QC testing requirements and status of activities.
- Prioritize efficient workflow between samples and the shift.
- Attend manufacturing departmental meetings and communicate shift issues and production delays with possible corrective actions and implementation plan.
- Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of “non-value added” activities.
- Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
- Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.
- Completes any other duties/responsibilities assigned by senior management.
• Bachelor degree in a relevant scientific discipline (Chemistry, Biology, Biochemistry, etc.)
• 5 years' quality control experience in the pharmaceutical/biotech/or other regulated industry or proven knowledge in the role may be considered
• Leadership/ team management skills
• Effective oral and written communication skills
• Possesses a thorough knowledge of quality systems
• Problem solving skills
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
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About CSL Behring
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.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.
Do work that matters at CSL Behring!