JT713 - SR. SPECIALIST QA

Hace 3 semanas
Juncos, Puerto Rico Quality Consulting Group, LLC Jornada completa
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:
- Approve process validation protocols and reports for mfg. processes
- Represent Quality on incident triage team
- Approve Environmental Characterization reports
- Release of sanitary utility systems
- Approve planned incidents
- Represent QA on NPI team
- Lead investigations
- Own site quality program procedures
- Designee for QA manager on local CCRB
- Project management skills
- Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and processes development

Qualifications:
- Bachelor's degree and 6 years of directly related experience
- Experience with Facilities and Utilities Commissioning and Qualification (C&Q)
- Knowledge and experience in Computer System Validation (CSV)
- Experience with Equipment Validation
- Experience conducting Risk Assessments and applying risk-based methodologies
- Proficiency with systems and platforms such as KNEAT, C-DOCS, SCADA, TrackWise, and Maximo
- Strong knowledge of Good Documentation Practices (GDP) and Data Integrity principles
- Experience with Change Control processes
- Knowledge and experience developing, reviewing, and updating Standard Operating Procedures (SOPs)
- Experience with Syringe and Vial Inspection Processes
- Experience with Document Revision and Approval processes
- Strong knowledge of Decision-Making Techniques
- Strong knowledge of Risk Management principles and practices
- Ability to assess risks, analyze complex situations, and make sound decisions in accordance with applicable procedures, quality standards, and regulatory requirements

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