“This company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and PuertRictbe vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations tstaff augmentation external workers whqualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship tthis company, its operations, or its staff.”
Top 3 Must Have Skill Sets:
Experience in a GMP environment, Quality Assurance experience, audit experience
Day to Day Responsibilities:
Successfully oversee manufacturing operations through purposeful presence, perform electronic batch record review on the manufacturing floor, coach staff in Good Documentation Principles..
Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Deviations
Oversee and provide guidance during on-the-floor analytical testing.
Ensures that changes that could potentially impact product quality are assessed according to procedures.
Ensures that deviations from established procedures are investigated and documented per procedures.
Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
Alerts senior management of quality, compliance, supply and safety risks.
Completes required assigned training to permit execution of required tasks.
"This posting is for Contingent Worker, not an FTE"