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.