“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and  puerto rico vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”                                                        

Top 3 Must Have Skills                                                                            

• Technical writing experience (i.e. deviation records, CAPA records, controlled documents)
• Excellent verbal and written cross functional communication skills
• Must have biotech/pharma manufacturing, quality assurance, or quality control experience
• Biotech/ Pharma experience required***
• Must be able to work swing, morning, evenings, night shift (24/7 Operation building). Once trained it will 4 day work week.

Day to Day Responsibilities:                                

• Purposeful presence on the manufacturing floor (80% of working time spent on MFG floor in controlled, classified cell culture and protein purification areas).
• Batch record review
• SOP and MP revision approval
• work order approval
• quality approval of deviations and CAPAs
• Safety auditing and observational work
• GEMBA walks

"This posting is for Contingent Worker, not an FTE"