Specialist QA 35053
hace 2 semanas
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.
Administrative Shift (8hrs Monday to Friday, available nonstandard as needed.
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:
- NPI, Change Control, Documentation Review, Validation, C&Q, PPQ, FAT
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.
- Bachelor's degree in sciences/engineering
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