Overview
Specialist QA 34334 Jobs in Municipio de Juncos, PR at Inteldot
Full Job Description
Inteldot has over 14 years in the life sciences industry with allocations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Third Shift (9:00pm – 5:30am) Monday – Friday
Job Description
Under minimal supervision, candidate should provide Quality Oversight related to Manufacturing, Warehouse, Distribution, Supply Chain and Incoming Operations.
Requirements:
Experience performing Quality Oversight
Supporting Supply Chain & Incoming operations experience
Fully Bilingual (Spanish and English)
Functions:
Compliance Monitoring: Oversee adherence to cGMP (current Good Manufacturing Practices). Review and approve SOPs, batch records, validation documents, and deviation investigations. Monitor manufacturing operations for compliance in real time.
Deviation & CAPA Oversight: Ensure timely investigation of non-conformances and deviations. Review and approve CAPA (Corrective and Preventive Actions) plans.
Change Control: Assess and approve change controls to ensure no adverse impact on product quality or regulatory compliance.
Batch Release: Perform batch record reviews and approve product release for distribution.
Regulatory Support: Prepare for and support regulatory inspections (e.g., FDA, EMA). Ensure inspection readiness at all times.
Quality Metrics & Reporting: Track and report quality performance metrics. Identify trends and drive continuous improvement.
Training and Mentorship: Train manufacturing, laboratory, and support staff on quality systems and GMP compliance.
Education
Doctorate or Masters + 2 years of directly related experience or Bachelors + 4 years of directly related experience (Life Sciences or Engineering)
Title: Specialist QA 34334
Company: Inteldot
Location: Municipio de Juncos, PR
Category:
