Kankakee, Illinois, United States · On-site
The Opportunity: This role serves as a GCP Auditor within our Research & Development Quality audit program, responsible for executing the global audit plan to ensure the accuracy of clinical trial data and compliance wit…
Skills: GCP Auditing, Clinical Trial Management, CAPA Development, Risk Categorization, Trend Analysis
Dallas, Texas, United States · On-site
Responsibilities: • Under general supervision, responsible for evaluating donor suitability for automated pheresis procedures • Provides limited emergency medical care to donors and staff including administering medicati…
Skills: Donor Suitability Evaluation, Emergency Medical Care, Medical History Review, Physical Assessment, Plasma Collection
Mobile, Alabama, United States · Remote OK
Responsibilities: • Drives sales results to achieve / exceed specific sales volume, revenue, and profitability targets. • Deliver flu portfolio product sales in key accounts including Pediatrics, IDN, FQHCs, independent/…
Skills: Pharmaceutical Sales, B2B Sales, Account Management, Strategic Planning, Communication Skills
King of Prussia, Pennsylvania, United States · On-site
Position Purpose: The Sr. Manager, Medicaid Operations leads development, implementation, and management of processes, programs, and policies to ensure that CSL adheres to all compliance requirements outlined in the Medi…
Skills: Medicaid Drug Rebate Program, Tricare, Medicare, Claims Processing, Dispute Resolution
Lawrence, Kansas, United States · On-site
Responsibilities: • Responsible for preparing the donor, donor area and equipment for the pheresis process. • Prepares the autopheresis machine for the pheresis process. • Monitors the donor and the pheresis process, res…
Skills: Pheresis Process, Donor Support, Medical Equipment Operation, Patient Monitoring, Data Recording
Dallas, Texas, United States · On-site
Responsibilities: • Under direct supervision, assists with daily activities pertaining to shipping, receiving and storage • Physically moves and maintains flow of materials and products following established procedures a…
Skills: Shipping, Receiving, Storage, Material Handling Equipment, SAP
Chicago, Illinois, United States · On-site
$18/hr–$20/hr
Job Description Summary Responsible for minor maintenance repairs and the clean and orderly appearance of the collection center. Job Description 1 Cleans table, chairs, cabinets, counters and appliances located in the …
Skills: Janitorial Services, Minor Maintenance, Plumbing, Carpentry, Painting
Westland, Michigan, United States · On-site
Responsibilities: • Responsible for preparing the donor, donor area and equipment for the pheresis process. • Prepares the autopheresis machine for the pheresis process. • Monitors the donor and the pheresis process, res…
Skills: Pheresis Process, Donor Support, Medical Equipment Operation, Patient Monitoring, Data Recording
Hidalgo del Parral, Chihuahua, Mexico · On-site
$85k–$93k/yr
The Opportunity This position is responsible for supervising the day-today plasma center operations and staff to ensure efficient plasma collections. You will report to the Center Manager. The Role In compliance with Sta…
Skills: Staff Supervision, Operational Management, Performance Management, Compliance Monitoring, Process Improvement
Youngstown, Ohio, United States · On-site
Responsible for the efficient and effective collection of plasma from donors by performing venipuncture, monitoring the pheresis process and following Standard Operating Procedures (SOPs). Job Description: 1 In complianc…
Skills: Phlebotomy, Venipuncture, Pheresis, Donor Monitoring, Bilingual English/Spanish
Lawrence, Kansas, United States · On-site
Responsibilities: • Responsible for preparing the donor, donor area and equipment for the pheresis process. • Prepares the autopheresis machine for the pheresis process. • Monitors the donor and the pheresis process, res…
Skills: Pheresis Process, Donor Support, Medical Equipment Operation, Patient Monitoring, Data Recording
Houston, Texas, United States · On-site
Responsibilities: • Responsible for preparing the donor, donor area and equipment for the pheresis process. • Prepares the autopheresis machine for the pheresis process. • Monitors the donor and the pheresis process, res…
Skills: Pheresis Process, Donor Care, Medical Equipment Operation, Data Recording, Patient Monitoring
Yeadon, Pennsylvania, United States · On-site
The Opportunity Responsible for preparing the donor, donor area and equipment for the pheresis processors. You will report to the Assistant Center Manager. The Role Prepares the autopheresis machine for the pheresis proc…
Skills: Pheresis Processing, Donor Care, Medical Equipment Operation, Data Entry, Patient Monitoring
Hidalgo del Parral, Chihuahua, Mexico · On-site
Summary Responsible for training and coaching the reception staff and facilitating efficient donor flow through the center. Additional duties include registration of qualified, applicant and transfer donors. Possesses a …
Skills: Staff Training, Coaching, Donor Screening, Customer Service, Equipment Calibration
Jersey City, New Jersey, United States · Remote OK
Responsibilities: • Drives sales results to achieve / exceed specific sales volume, revenue, and profitability targets. • Deliver flu portfolio product sales in key accounts including Pediatrics, IDN, FQHCs, independent/…
Skills: Sales Results, Account Management, Strategic Planning, B2B Sales, Communication Skills
San Jose, California, United States · Remote OK
Responsibilities: • Drives sales results to achieve / exceed specific sales volume, revenue, and profitability targets. • Deliver flu portfolio product sales in key accounts including Pediatrics, IDN, FQHCs, independent/…
Skills: Sales Results, Account Management, Strategic Planning, B2B Sales, Communication Skills
Margate, Florida, United States · On-site
Responsibilities: • Responsible for the efficient and effective collection of plasma from donors by performing venipuncture, monitoring the pheresis process and following Standard Operating Procedures (SOPs). • In compli…
Skills: Phlebotomy, Venipuncture, Plasma Collection, Donor Monitoring, Bilingual English/Spanish
Hidalgo del Parral, Chihuahua, Mexico · On-site
The Opportunity This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable loc…
Skills: Quality Assurance, Regulatory Compliance, Internal Auditing, Corrective Action Planning, Training Management
Haltom City, Texas, United States · On-site
Responsibilities: • Responsible for preparing the donor, donor area and equipment for the pheresis process. • Prepares the autopheresis machine for the pheresis process. • Monitors the donor and the pheresis process, res…
Skills: Pheresis Process, Donor Care, Medical Equipment Operation, Data Recording, Patient Monitoring
Westland, Michigan, United States · On-site
Responsibilities: • Responsible for the evaluation of donor suitability for automated pheresis procedures. Administration and supervision of approved immunizations other than red blood cell immunizations. Provides limite…
Skills: Donor Suitability Evaluation, Medical History Review, Health Assessment, Emergency Medical Care, Immunization Administration
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Execute the global audit plan by conducting audits of clinical investigator sites, CROs, and internal processes to ensure data accuracy and compliance. Identify non-compliance trends and collaborate with stakeholders to develop corrective and preventive actions (CAPA).
Requires a BS degree in biological science or a related field and at least 3 years of Quality Assurance experience in a GCP-regulated environment. Must possess deep knowledge of ICH E6 and various FDA 21 CFR regulations, with the ability to travel up to 50%.
This role serves as a GCP Auditor within our Research & Development Quality audit program, responsible for executing the global audit plan to ensure the accuracy of clinical trial data and compliance with legal and corporate standards.
By conducting audits of our clinical investigator sites, external vendors, and internal trial management processes, you identify the findings and non-compliance trends that could impact the integrity of our clinical research. Seeking an experienced auditor who can navigate complex clinical environments and work collaboratively with stakeholders to develop corrective actions that ensure long-term systemic stability.
Audit Execution: Conduct assigned external audits of clinical investigator sites, Contract Research Organizations (CROs), E-System providers, and Institutional Review Boards (IRBs/ECs).
Reporting & Risk Categorization: Develop and issue comprehensive Audit Reports, categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA) related to trial conduct and data integrity.
Trend Analysis: Identify non-compliance trends and systematic risks within the Clinical (GCP) discipline, communicating these findings to line management and clinical functional leads to ensure trial robustness.
Continuous Improvement: Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk-based, compliant solutions for clinical trial management and monitoring.
Regulatory Knowledge: Maintain up-to-date knowledge of global GCP regulations (ICH E6) and industry trends, identifying new requirements to ensure a high level of quality is maintained across all clinical development programs.
Academic Background: BS degree in a relevant biological science, science, or related discipline
Professional Experience: 3+ years of Quality Assurance experience within a GCP-regulated environment, demonstrating a strong understanding of clinical trial phases, monitoring, and regulatory frameworks.
Audit Expertise: Experience in clinical audit and inspection management, with a clear understanding of the requirements for quality assurance in the clinical research discipline.
Communication Skills: Excellent interpersonal and negotiation skills, with the ability to work effectively with multinational clinical teams, investigators, and external CROs.
ICH E6 (R3) Guideline
21 CFR Part 11 – Electronic Records; Electronic Signatures
21 CFR Part 50 – Protection of Human Subjects (Informed Consent)
21 CFR Part 312 – Investigational New Drug Application
21 CFR Part 812 – Investigational Device Exemptions
Clinical Trials Regulation (CTR) (EU) No 536/2014
Directive 2001/20/EC (Clinical Trial Directive)
Directive 2005/28/EC (GCP Directive)
Directive 2001/83/EC (Annex I)
Organizational Agility: Strong analytical and problem-solving skills, with the ability to work with limited supervision and manage a schedule that includes up to 50% travel.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
CSL is a leading global biopharma company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our businesses, CSL Behring, CSL Seqirus, and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 29,000+ people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. See our community guidelines: https://bit.ly/3Bs17Ra
Offices: 655 Elizabeth St, Melbourne, Victoria 3000, AU · 1020 1st Ave, King of Prussia, PA 19406, US
CSL is a leading global biopharma company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our businesses, CSL Behring, CSL Seqirus, and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 29,000+ people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. See our community guidelines: https://bit.ly/3Bs17Ra
Offices: 655 Elizabeth St, Melbourne, Victoria 3000, AU · 1020 1st Ave, King of Prussia, PA 19406, US
