GMP Compliance Expert
5 days ago
This Biopharmaceutical Documentation Manager position requires a highly organized individual with strong technical knowledge of GMP manufacturing operations. You will support the development and revision of documentation, lead investigations, and manage change controls.
Estimated Salary: $90,000 - $115,000 per year
Key Responsibilities:- Develop and revise SOPs, batch records, and other documentation to ensure accuracy and compliance.
- Investigate nonconformances and deviations, conducting root cause analysis and drafting reports.
- Collaborate with cross-functional teams to implement changes and improvements.
- Ensure timely completion of tasks and maintain quality standards.
- Stay up-to-date with regulatory requirements and industry best practices.
- Bachelor's degree in a relevant field, such as biology or biochemistry.
- Minimum 2 years of experience in biopharmaceutical GMP manufacturing operations.
- Strong technical knowledge of aseptic processing in cleanroom environments.
- Excellent communication and leadership skills.
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GMP Compliance Officer
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GMP Training Program Manager
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Cell Therapy Manufacturing Expert
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GMP Cell Therapy Specialist Lead
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Aseptic Manufacturing Expert
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Compliance Operations Expert
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Biopharmaceutical Documentation Manager
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MSAT Specialist
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Senior Director of GMP QC
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Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full timeAbout UsIovance Biotherapeutics Inc is a biotech company dedicated to developing innovative cancer therapies. We're driven by a passion to make a difference in the lives of patients and their families. Our team is composed of talented individuals who share a commitment to excellence and a dedication to advancing medical science.Job DescriptionWe're seeking...
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Aseptic Manufacturing Expert
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Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full timeResponsibilitiesDevelop a Subject Matter Expert (SME)-level understanding of Iovance GMP cell therapy manufacturing process(es) and execute as skillfully as well as troubleshoot.Assist with identifying training needs, establishing a feedback loop to ensure continuous improvement.Deliver training sessions and ensure training documentation is maintained.This...
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Chemical Analyst and Documentation Expert
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