Specialist QA (34959)

Inteldot has over 14 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Job Description:

Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities. 

Responsibilities:

• Review and approve product Master Plans (MPs).
• Approve process validation protocols and reports for manufacturing processes.
• Participate in Quality on Incident Triage Team.
• Approve Environmental Characterization reports.
• Release sanitary utility systems.
• Approve planned incidents.
• Represent QA in the New Product Introduction (NPI) team.
• Lead investigations and site audits.
• Own and maintain site quality program procedures.
• Serve as QA Manager designee on local Change Control Review Board (CCRB).
• Review and assess risk evaluations.
• Support automation activities, facilities, and environmental programs.
• Review and approve Work Orders and EMS/BMS alarms.
• Approve non-conformance (NC) investigations and CAPA records.
• Approve change controls

Job Requirements:

• Experience supporting fill–finish (filling line) operations.
• Solid knowledge of aseptic manufacturing processes.
• In-depth knowledge of equipment, process, and cleaning validation activities from a Quality function, including protocol review, data evaluation, deviation assessment, and final approval to ensure cGMP compliance.
• Understanding of change control management.
• Experience with Annual Product Review (APR) / Periodic Review processes.
• Knowledge of process monitoring and ongoing process verification.

Education & Experience:

• Doctorate or Masters + 2 years of directly related experience or Bachelors + 4 years of directly related experience or Associates + 8 years of directly related experience or High school/GED + 10 years of directly related experience.