Specialist QA 34571
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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.
Administrative shift
Job Description
Perform one or more of the following duties and responsibilities in support of site Quality Assurance program under minimal supervision.
Requirements:
- Quality Professional with Validations and Commissioning & Qualifications of manufacturing equipment and laboratory bench equipment experience (IOQ PQ Functional Test). In addition to Technical Writing Quality Systems (Deviations Change Control) and Maintenance (PM Work Orders Job Plans review and approval) knowledge. Technical Documents review (Validation Reports Procedures Forms).
- 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
Key Skills
- Invoicing
- Information Technology Sales
- IT Support
- Audio Visual
- Database Administration
About Company
Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients Segoe UI in Puerto Rico.Description:Under general supervision, provides characterization of process ... View more
