“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        

• Self starter
• Attention to detail
• Good written and oral communication
• Regulated environment experience/ understanding of regulations **

Day to Day Responsibilities:    

• Perform receipt, manufacturing, storage, distribution, and Facilities & Engineering documentation review to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
• Perform cGMP process, procedure, document and record review, approval and tracking, including but not limited to Deviations, CAPAs, Change Controls, and Validations. May also support execution of these tasks.
• Perform routine Quality Assurance assessments of site operations and provide direct oversight.
• Support Labeling and Packaging Operations including incoming raw material inspection and manufacturing oversight.
• Represent the Quality Unit during audits and inspections as needed.
• Support internal/external audits and inspections as part of the audit/inspection team as needed.
• Perform additional duties as specified by management

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