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The Process Lead participates in the manufacture of Leukocyte Interleukin, Injection (LI) under cGMP for clinical application, and facilities operations and maintenance. Understanding and awareness of current Good Manufacturing Practices (cGMP) and basic familiarity with FDA and EU Guidelines.
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The Manufacturing Associate I perform and documents cGMP activities to support upstream or downstream production areas and operations. Documents/Records cGMP data and information for processing steps and/or equipment activities, following standard operating procedures.
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This involves operation of process equipment, execution of validation protocols, completion of cGMP documents, creating/ revising cGMP documents and other assignments as directed. Understands basic cGMP requirements and follows those requirements, including requirements for good documentation practices.
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All duties are performed in compliance with FDA cGMP/cGTP requirements, American Association of Tissue Banks (AATB) standards, and Osiris Therapeutics Inc. standard operating procedures (SOPs.
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Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program. Assist with technology transfer from R&D to manufacturing environment.
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Education: High School Diploma required Associate's degree in a life science preferredExperience: 0-5 years of experience in a manufacturing setting Familiar with aseptic technique preferred. Follow batch production records (BPRs) and SOPs to manufacture human tissue products.
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Perform quality inspections of products and packaging equipment, recording any defects and ensuring compliance with safety and quality standards according to SOPs and cGMP. This role combines the essential functions of a Warehouse Packer / Material Handler and a Forklift Operator, focusing on the logistics of receiving, processing, storing, and shipping inventory according to purchase orders and shipping schedules.
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Authors and reviews technical reports, process tech transfer summary reports, master batch records, product and equipment specifications, and protocols in support of tech transfer and cGMP activities.
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Job Title: Manufacturing AssociateLocation: Harmans, MDDuration: Months on W (Temp-to-Hire) Shift: AM - PM : Rotating Schedule Every Weeks ON, OFF, ON, OFF, ON AND OFF. POSITION SUMMARY:The Manufacturing Associate : Perform and Documents cGMP activities to support upstream or downstream production areas and operations.
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SUMMARY:The Manufacturing Associate I perform and documents cGMP activities to support upstream or downstream production areas and operations. SUMMARY:The Manufacturing Associate I perform and documents cGMP activities to support upstream or downstream production areas and operations.
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