Specialist QA-DS

Ultimate Solutions•Puerto Rico, PR

About The Position

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.

Requirements

Master’s degree and 2 years of directly related experience or Bachelor’s degree and 4 years of directly related experience Bachelor Science
Expericence in Quality and Compliance
Experience with validation protocols and reports for clean utilities, manufacturing processes, cleaning processes, equipment, computerized systems, change control records, deviations,etc.
Experience in biological processes desired
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