Job Description
We are seeking a Senior QA Specialist with proven experience in the review and approval of documentation related to syringe packaging inspection lines. The ideal candidate will have hands-on experience supporting commissioning and qualification activities, equipment validation, and quality systems compliance within a regulated bio-pharma environment.
Preferred qualifications include experience with Kneat (validation software), Maximo, and CDocs platforms. The successful candidate will possess a strong understanding of Quality Risk Assessments (QRAES), Good Documentation Practices (GDP), Change Control processes, Standard Operating Procedures (SOPs), and applicable GMP requirements. Excellent document management, compliance oversight, and cross-functional collaboration skills are essential.
Requirements
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.
Sr Specialist QA • Juncos, PR, pr
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