Specialist QA 34334
Specialist QA 34334
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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)
Required Experience:
Unclear Seniority
Employment Type
Full-Time
