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 directly related experience or; Masters + 4 years of directly related experience or Bachelors + 6 years of directly related experience or Associates + 10 years of directly related experience or; High school/GED + 12 years of directly related experience. Bilingual (English & Spanish)
QRC group is a life science firm dedicated to provide services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Our services and solutions include:
Process and Laboratory Investigation
• Corrective and Preventive Action (CAPA)
• Change Control
• Training
• Document Management Control
• QA Laboratory
• Methodology Transfer and Validation
• Instrument Calibration
• Validation and Training in Chromatographic Data Acquisition System
• Cleaning Validation
• Automation Engineering
• Quality Systems
