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DESCRIPTION

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

Master’s degree and 2 years of Quality experience or Bachelor’s degree and 4 years of Quality experience.

Science or Engineering preferred.

REQUIREMENTS

- Experience in NPI, Change Control, FAT's, Validation and PPQ's documentation review.
- Project management skills.




- Strong organizational skills, including ability to follow assignments through to completion.
- Initiate and lead cross functional teams.
- Enhanced skills in leading, influencing and negotiating.
- Strong knowledge in area of expertise.
- Collaborate and coordinate with higher level outside resources.
- Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
- Demonstrate ability to interact with regulatory agencies.
- Strong communication (both written and oral), facilitation and presentation skills.
- Strong skill in working independently and to effectively interact with various levels.
- Advanced data trending and evaluation.
- Ability to evaluate compliance issues.

Ultimate Solutions Corp is an Equal Opportunity Employer.

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Postúlate en Kit Empleo: kitempleo.com.co/empleo/1azgf0

📌 Specialist QA-inspection & Packaging (Puerto Rico)
🏢 Ultimate Solutions
📍 Puerto Rico