Specialist QA – Quality Assurance (Life Sciences)

About the role

This position supports the Quality Assurance program for a leading life‑sciences client in Puerto Rico. Working with minimal supervision, you will ensure manufacturing processes, validation activities, and regulatory compliance meet the highest standards.

Key responsibilities

• Review and approve product manufacturing procedures (MPs) and process validation protocols.
• Approve environmental characterization reports, sanitary utility releases, and planned incidents.
• Represent QA on New Product Introduction (NPI) teams and lead investigations, site audits, and CAPA activities.
• Manage change controls, risk assessments, and NC investigations.
• Provide lot disposition decisions and authorize shipments.
• Support automation, facilities, and environmental programs, including EMS/BMS alarm reviews.
• Maintain site quality program procedures and act as QA manager designee for the local CCRB.

Required profile

• Master’s degree with at least 2 years of relevant experience, or a Bachelor’s degree with 4 years.
• Strong organizational and project‑management abilities.
• Experience with manufacturing, QA, validation, and process development in a regulated environment.
• Proven ability to interact with regulatory agencies and lead cross‑functional teams.
• Excellent written and oral communication, presentation, and data‑analysis skills.

Required skills

• Change Control
• Documentation Review
• Validation (including PPQ)
• Project Management
• Data Trending and Evaluation
• Regulatory Compliance
• Automation Support
• EMS/BMS Alarm Review
• CAPA Management
• Lot Disposition