Quality Assurance Scientist

Location: Manati, Puerto Rico
Date Posted: 05-03-2018
The Quality Assurance Scientist will provide support to the manufacturing area (Parenteral, Oral Solid Dosage) to assure that the operations are performed in compliance with Domestic and International regulations, site policies and procedures. Execute all quality assurance activities related with review and approval of the GMP documents such as batch records, investigations, CAPAs (Corrective Actions&/Preventive Actions), Annual Product Review, protocols, procedures, qualification and validation reports. Ensure the compliance of Corporate and HR Policies, FDA, GMP, internal/external audit, and any other regulatory requirements. Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job.

  • Bachelor Degree in Science, Chemical Engineering, Biology, Pharmacy or Microbiology
  • 3 years of experience in the pharmaceutical industry
  • Experience in Isolation Technology and/or Aseptic Area
  • Experience in parenterals and syringes Inspection and Packaging
  • Strong knowledge of relevant GMP, FDA, EU regulations and the ability to interpret and apply them for intended use
  • Knowledge of problem solving and root cause analysis methodologies
  • Experience in AQL sampling, parenterals products and QA
  • Trackwise and SAP
  • Fully bilingual (Spanish/English)

Ultimate Solutions Corp is an equal opportunity employer.
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