Inteldot has over 14 years of experience in the life sciences industry, with allocations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Summary:
Perform one or more of the following duties and responsibilities in support of client's program under minimal supervision.
Administrative Shift: 8 hours
Requirements:
• Perform Trackwise system queries, deviations
• Participate in triage process
• Perform oversight of the process and procedures/GMP tasks
• Manage Change Controls and deviations for review and approval as QA contact
• Work with operations to resolve basic compliance discrepancies
• Knowledge in Validations and Laboratory area and equipment
• Strong organizational skills, including ability to follow assignments through to completion.
• Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.
• Microsoft Office spreadsheet and application skills and presentation knowledge.
• Strong communication (both written and oral), facilitation and presentation skills. Fully Bilingual in English and Spanish.
• Validated skill in working independently and to optimally interact with all levels throughout the organization.
Functions:
- Review and approve product MPs.
- Approve process validation protocols and reports for manufacturing processes. - Request Quality on incident triage team.
- Approve Environmental Characterization reports.
- Release of sanitary utility systems.
- Approve planned incidents.
- Represent QA on NPI team.
- Lead investigations.
- Lead site audits.
- Own site quality program procedures.
- Designee for QA manager on local CCRB.
- Review Risk Assessments.
- Support Automation activities.
- Support facilities and environmental programs.
- Review and approve Work Orders.
- Review and approve EMS/BMS alarms.
- Approve NC investigations and CAPA records.
- Approve change controls.
- Provide lot disposition and authorize lots for shipment.
Education:
Bachelor's degree and 5 years of directly related experience
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What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing. We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
