Overview
Quality Assurance Specialist Jobs in Juncos, Puerto Rico at BioPharma Consulting JAD Group
Title: Quality Assurance Specialist
Company: BioPharma Consulting JAD Group
Location: Juncos, Puerto Rico
The Senior Quality Assurance Specialist will perform key duties to support Quality Assurance program with minimal supervision. This role ensures compliance with GMP regulations, oversees manufacturing quality processes, and leads investigations and audits to maintain the highest product quality standards.
Key Responsibilities
Review and approve product Master Plans (MPs)
Approve process validation protocols and reports for manufacturing processes
Serve as the Quality representative on incident triage teams
Approve Environmental Characterization reports
Release sanitary utility systems
Approve planned incidents
Represent Quality Assurance (QA) on New Product Introduction (NPI) teams
Lead quality investigations and root cause analyses
Lead site audits to ensure regulatory compliance
Own and maintain site quality program procedures
Act as a designee for the QA Manager on local Change Control Review Board (CCRB)
Review risk assessments to identify and mitigate potential quality issues
Support automation activities and implementation of quality controls
Oversee facilities and environmental programs to maintain compliance
Review and approve work orders for equipment and facility maintenance
Review and approve EMS/BMS (Environmental and Building Management System) alarms
Approve non-conformance (NC) investigations and corrective and preventive actions (CAPA)
Approve change control records to ensure compliance with quality standards
Provide lot disposition and authorize product shipments
Skills:
Project management skills with the ability to lead cross-functional teams
Strong organizational skills and ability to manage assignments through to completion
In-depth knowledge of manufacturing, distribution, validation, and process development
Experience interacting with regulatory agencies and ensuring GMP compliance
Strong analytical and data evaluation skills
Excellent communication, facilitation, and presentation abilities
Ability to work independently and collaborate across various levels of the organization
Requirements
Qualifications
Doctorate degree OR
Master’s degree and 3 years of directly related experience OR
Bachelor’s degree and 5 years of directly related experience OR
Associate’s degree and 10 years of directly related experience OR
High school diploma/GED and 12 years of directly related experience
Strong experience in Quality Assurance, including deviations, preventive maintenance, job plans, change control, and Failure Modes and Effects Analysis (FMEA)
Expertise in leading, influencing, and negotiating across multiple teams
Proficiency in quality management systems and electronic documentation tools
Benefits
Administrative Shift
