Specialist QA

Puerto Rico - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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

Masters degree and 2 years of Quality experience or Bachelors degree and 4 years of Qualtiy experience

Science or Engineering preferred

REQUIREMENTS

Experience in NPI Change Control FATs Validation and PPQs 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 word processing presentation database and spreadsheet application skills.
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.

Required Experience:

DESCRIPTIONReview 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. ...