Specialist QA
Juncos - Puerto Rico
Job Summary
- Education: Doctorate or Masters 2 years of directly related experience or Bachelors 4 years of directly related experience.
- Perform comprehensive Batch Record Review to ensure completeness accuracy compliance and adherence to approved procedures and GMP requirements.
- Experience performing Batch Record Review in a GMP-regulated environment.
- Strong knowledge of GMP GDP and Data Integrity requirements.
- Experience with SAP inventory management and material reconciliation.
- Experience using PAX and/or Electronic Batch Record (eBR) systems.
- Ability to assess quality/compliance issues and apply risk-based decision making.
- Experience participating in manufacturing and quality operations meetings.
- Strong organizational skills and ability to manage multiple priorities with minimal supervision.
- Fully Bilingual (English & Spanish).
Required Skills:
Education: Doctorate 2 years of Project Management experience or Masters 4 years of Project Management experience or Bachelors 6 years of Project Management experience or Associates 10 years of Project Management experience or High school/GED 12 years of Project Manage Change Control experience Fluent business English and Spanish written and oral Effective verbal and written communication skills (writing and presentations). Understanding and experience with Ariba Sourcing and Contracting Modules. Experience with SAP Trackwise and Project management tools preferred. Highly proficient with MS Office including Excel Word and PowerPoint Practical project management software and spreadsheet skills proficient computer operation skills.