QA Specialist Job at BioLife Pharma Services | BA & BS Life Science Graduates Apply
BioLife Pharma Services, a division of Takeda, is hiring a Quality Assurance Specialist I in Van Nuys, California (Job ID: R0162343). This hybrid role offers a unique opportunity to work with industry-leading plasma and biopharmaceutical operations while ensuring compliance with global quality standards. If you are passionate about quality systems, regulatory excellence, and driving continuous improvement in the biotech industry, this position could be the right fit for your career growth.
- Job Position: Quality Assurance Specialist I
- Location: USA – CA – Van Nuys
- Job ID: R0162343
- Base Salary Range: $56,000.00 – $88,000.00 (dependent on qualifications and experience).
About the Company
BioLife Pharma Services, part of Takeda, is a global leader dedicated to transforming patient care through the development of specialty pharmaceuticals and innovative patient support programs. Certified as a Global Top Employer, Takeda provides an inclusive and collaborative work environment that promotes innovation and career growth. The company is committed to delivering Better Health and a Brighter Future for patients worldwide.
Education
BS degree in Life Sciences
Experience
- Minimum 2 years of experience in the Plasma/Whole Blood Industry or Biotech.
- Minimum 2 years in a quality organization preferred.
- Proficiency in MS Office (Word, Excel, Visio, PowerPoint).
- Knowledge of regulatory, quality, and FDA requirements (cGMP, GDP).
- Experience with APDS, TrackWise, C3ME, or similar systems.
- Proficiency in Qlik and Power BI for reporting.
- Strong communication, organizational, and problem-solving skills.
- Forklift certification is desirable.
Job Description
As a QA Specialist, you will be responsible for managing Deviations (Events) and Corrective and Preventive Actions (CAPAs) within Takeda’s Quality Systems. The role involves close collaboration with plasma suppliers, tracking discrepancies, ensuring compliance, and preparing performance metrics to support effective decision-making. You will report to the Supervisor, Quality Systems, and contribute to Takeda’s mission of delivering high-quality plasma and biopharmaceutical products. This is a hybrid role that requires an in-office presence three days a week.
QA Specialist Key Responsibilities:
- Manage and resolve deviations and CAPAs in Quality Systems
- Conduct process audits and ensure regulatory compliance
- Oversee Quality vault management and document control
- Review and revise department procedures
- Perform quality reviews/dispositions of plasma lots and shipments
- Lead continuous improvement projects and audits
- Prepare and deliver process performance updates to stakeholders
QA Specialist Job Important Considerations:
- Physical requirements include lifting to 50 lbs, working in cold temperatures, and standing for prolonged periods.
- Ability to work multiple shifts and weekends as needed
Benefits:
Various benefits include medical, dental, vision insurance, 401(k) plan, disability coverage, life insurance, tuition reimbursement, paid time off, and more.
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