Quality Assurance Scientist

  • Full-time

Company Description

Validation & Engineering Group (VEG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

Job Description

Provide support to the manufacturing area (Aseptic Experience required) to assure that the operations are performed in compliance with Domestic and International regulations. Execute all quality assurance activities related with review and approval of the GMP documents such as batch records, investigations, CAPAs. Annual Product Review, protocols, procedures, qualification and validation reports. Ensure the compliance of Corporate and  FDA, GMP, internal/external audit, and any other regulatory requirements. 

Qualifications

  • Bachelor Degree in Science, Chemical Engineering, Biology, Pharmacy or Microbiology.
  • Minimum of  3 years of experience in the parenteral or biotechnology industry. 
  • REQUIRED Experience in manufacturing operations of Parenteral Products Manufacturing.
  • Strong knowledge of relevant CAPA, GMP, FDA, EU regulations and the ability to interpret and apply them for intended use. 
  • Fully bilingual (Spanish/English) communication skills, both written and verbal are required.
  • Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results.
  • Knowledge of problem solving and root cause analysis methodologies.
  • Experience in Batch Record Review, parenteral products and QA.

Additional Information

Positions available for Puerto Rico.

Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.