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Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.
Job Responsibility:
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:
Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience
Experience 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
Demonstrate the Values/Leadership Practices
Nice to have:
Experience in biological processes desired
What we offer:
medical
dental
vision care
comprehensive suite of benefits focusing on physical, emotional, financial, and social aspects of wellness
support for working families (backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, paid caregiver leave)
training programs
professional development resources
opportunities to participate in mentorship programs, employee resource groups, volunteer activities