Holly Springs, North Carolina, United States · On-site
Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufac…
Skills: Quality Assurance, GMP, FDA Regulations, Aseptic Processing, Biotechnology
Wichita, Kansas, 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: Venipuncture, Plasmapheresis, Donor Monitoring, SOP Compliance, FDA Guidelines
Burton, Michigan, 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: Venipuncture, Plasma Collection, Pheresis Process, Donor Monitoring, Equipment Troubleshooting
São José da Laje, Alagoas, Brazil · On-site
The primary purpose of the Strategy & Corporate Development and Finance Coordinator is to provide comprehensive coordination, analyst and logistical support to the Strategy & Corporate Development. This includes managing…
Skills: Executive Administrative Support, Meeting Coordination, Financial Administration, Travel Coordination, Research and Analysis
Youngstown, Ohio, United States · On-site
The Opportunity Responsible for the accurate and timely sampling, testing, shipping and storage of plasma collected from donors. You will report to the Assistant Center Manager. The Role In compliance with Standard Opera…
Skills: Plasma Processing, Sampling, Sterile Technique, Equipment Calibration, Data Recording
Springfield, Missouri, 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, Patient Counseling
Kansas City, Missouri, United States · On-site
Responsibilities: • Responsible for greeting donors at the plasma collection center and conducting a series of registration procedures to verify donor suitability for the plasma pheresis process. • In compliance with Sta…
Skills: Customer Service, Medical Screening, Patient Registration, Vital Signs Monitoring, Phlebotomy Basics
Holly Springs, North Carolina, United States · On-site
Purpose Primary responsibilities for this position include performing tasks associated with release testing and reviewing laboratory data. The analyst will be responsible for ensuring that CSL Seqirus samples are collect…
Skills: Immunology Testing, Biochemistry Testing, GMP Compliance, ELISA, BCA
Kansas City, Missouri, 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, Pheresis Procedures, Medical History Review, Health Assessment, Emergency Medical Care
Edison, New Jersey, United States · On-site
$18/hr–$20/hr
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
Wilkes-Barre, Pennsylvania, United States · On-site
Job Description 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 dono…
Skills: Staff Training, Coaching, Donor Screening, Customer Service, Equipment Calibration
Terre Haute, Indiana, 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
Port Saint Lucie, Florida, United States · On-site
Responsible for the accurate and timely sampling, testing, shipping and storage of plasma collected from donors. You will report to the Assistant Center Manager. The Role · In compliance with Standard Operating Procedure…
Skills: Plasma Sampling, Sterile Technique, Equipment Calibration, Data Entry, Quality Control
Kankakee, Illinois, United States · On-site
$106k–$125k/yr
Position Purpose: Quality Manager – USA: The Quality Manager – USA serves two primary functions: 1) Support the QMS operations and 2) as the back-up Local Quality Officer (LQO) for the US Vifor Pharma, Inc and CSL Behrin…
Skills: Quality Management System, GMP Compliance, GDP Compliance, Product Technical Complaint Management, Regulatory Inspection Readiness
Summit, New Jersey, United States · On-site
Job Summary The Senior Manager, Customer Operations and Financial Reconciliation sets the strategy and leads execution of financial compliance, adjudication, and revenue protection across the commercial contract landscap…
Skills: Gross-to-Net Execution, Financial Reconciliation, Chargeback Adjudication, Revenue Protection, Contract Membership
Waltham, Massachusetts, United States · Hybrid
$230k–$270k/yr
CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that ex…
Skills: Strategic Planning, Operational Execution, Executive Coordination, Governance Management, Resource Optimization
Toledo, Ohio, 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
Dallas, Texas, United States · On-site
Responsibilities: • Responsible for greeting donors at the plasma collection center and conducting a series of registration procedures to verify donor suitability for the plasma pheresis process. • In compliance with Sta…
Skills: Customer Service, Medical Screening, Patient Registration, Vital Signs Monitoring, Phlebotomy Basics
Dothan, Alabama, United States · 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, Training Coordination, Corrective and Preventive Action (CAPA)
Gilbert, Arizona, 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 Recording, Patient Monitoring
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Manage a team of QA Specialists providing floor support to manufacturing, laboratories, and logistics. Lead quality decision-making on shift, ensure maintenance of quality systems, and oversee the review and approval of batch records and deviations.
Requires a Bachelor's degree in an engineering or scientific field and over 5 years of biopharmaceutical experience, specifically in biotechnology and aseptic processing. Demonstrated knowledge of GMPs and FDA requirements is essential, with supervisory experience preferred.
Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.
You will report to the Sr. Manager, FLQA and will manage one of the day shifts of QA professionals who provide floor support to manufacturing, laboratories, utilities, maintenance, and logistics. You will manage daily workload, performance management and development of direct reports. Additionally, you will lead quality decision making on shift and ensure maintenance of quality systems and provide technical support onsite at our Holly Springs, NC site. Benefits Include, Outdoor amenities, Onsite Café, Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.
Day Shift Hours: 6AM – 6PM, 2-2-3 Rotating Schedule
Responsibilities:
Manage a staff of QA Specialists to ensure coverage of shift workload. Includes the following:
Manage the required workload on shift by performing the following:
Main contact on shift for assessing and influencing quality issues arising throughout multiple areas of business:
To support team workload, performs the following FLQA core tasks:
Support regulatory inspections and site self-inspections as required
Qualifications
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
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.
Watch our ‘On the Front Line’ video to learn more about CSL Seqirus
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
