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Responsibilities

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