· Execute manufacturing processes on the floor under supervision, while rigorously following batch records, standard operating procedures (SOPs), and Current Good Manufacturing Practice (cGMP) regulations to ensure manufacturing operations are safe and compliant.
· Ensure right-the-first-time performance of all process steps specific to the step of operation, as well as help drive the safety-first culture at Kite Oceanside.
· Work as part of a team to execute Good Manufacturing Practice (GMP) runs in close collaboration with, Manufacturing Science and Technology (MSAT), Facilities and Engineering (F&E) and Quality departments.
· Under supervision, perform weighing of raw materials, as well as electronic inventory transactions utilizing Manufacturing Execution Systems (MES) and Enterprise Business system (EBS).
· Under supervision, perform Chromatography and Ultrafiltration/Diafiltration operations for the manufacturing of viral vector products in a cGMP environment using proper aseptic technique, proper cleanroom etiquette, Good Documentation Practices (GDP), and sound scientific methods.
· Prepare and use single use systems to support buffer preparation and filter integrity testing.
· Assist with manual and/or automated fill of harvested viral vector material.
· Escalate processing and equipment issues as needed.
· Assist with revisions of SOPs, Manufacturing Production Record (MPRs), and other controlled documents.
· Assist in the review of in-process cGMP documentation for completeness, accuracy, and compliance.
· Ability to work effectively in an inclusive, cross-functional, team-based environment.
· Able to work off shift hours and weekend.
· Additional duties as assigned.
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
Numbers & Facts
Location
Oceanside, CA
Salary
$30–$31.77 Per Hour
Skills
Asepsisunmatched
Business Solutionsunmatched
Chromatographyunmatched
Cleanroomunmatched
Cross-Functionalunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Document Managementunmatched
Documentationunmatched
Facilities Engineeringunmatched
GMP (Good Manufacturing Practices)unmatched
Inventory Transactionsunmatched
Manufacturingunmatched
Manufacturing Execution Systems (MES)unmatched
Manufacturing Operationsunmatched
Manufacturing Requirementsunmatched
Manufacturing/Industrial Processesunmatched
Standard Operating Procedures (SOP)unmatched
Team Playerunmatched
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