The schedule for this position is Tuesday through Saturday.
Overview
The QA Batch Release Auditor Plasma/Intermediates performs the final review and release of incoming plasma, in-house and export intermediates per assigned product lines; including the review of deviations, change controls, manufacturing records and laboratory data prior to assigning disposition decision.
Responsibilities
- Performs final review and release of plasma, in-house intermediates, export intermediates per assigned product line utilizing the Electronic Batch Release System, LOGIC and/or SAP; including overall review of deviations, change control, manufacturing records and laboratory data.
- Collaborates with the Plasma PLC and site Warehouse to ensure on-time release of plasma to meet manufacturing pooling schedule.
- Collaborates with other CSL sites to ensure on-time release of export intermediates to meet manufacturing plans.
- Collaborates with Scheduling to ensure in-house intermediates are released to meet manufacturing production requirements.
- Participate in global and local teams to work through cross functional and cross site initiatives.
- Supports audits (including internal and Health Authority) as subject matter expert for product lines which they are release responsible.
- Assists with the preparation or review of batch release documentation for regulatory requirements or customers.
- Assists with the maintenance of Kankakee pooling contracts in LOGIC.
- Responsible for the review and assessment of Post Donation Information (PDIs) for the ongoing risk assessment of plasma.
- Assists with the maintenance of Batch Release master data in SAP and the EBR.
- Assists with testing new functionality in SAP, ECP, QlikSense and BI dashboards are required.
- Assists with training within the Batch Release team and ensures personal training requirements remain current.
- Assists the Batch Release Manager with the compilation and review of batch lists for APQRs, audit requests and yearly FDA communication.
- Assists with the electronic archival of batch record documentation as required.
Qualifications
Education:
- Bachelor's degree preferably in a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.)
Experience:
- Minimum 3 years’ experience in pharmaceutical/biotech or other regulated industry.
- Knowledge of current Good Manufacturing Practices (cGMP) principles.
- Knowledge of GxP, domestic (FDA) and international regulations (EMA, PICs, etc.).
- Proficient in the Microsoft Office applications.
- Demonstrated experience in SAP, STARLIMS, and Veeva applications.
- Excellent organization skills and attention to detail.
The expected base salary range for this position at hiring is $57,000 - $72,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
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.
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As a global organization with employees in 35+ countries, CSL embraces inclusion and belonging. Learn more about Inclusion & Belonging at CSL.
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