Doctorate degree in Sciences/Engineering and 2 years of directly related experience or Master’s degree in Sciences/Engineering and 6 years of directly related experience or Bachelor’s degree in Sciences/Engineering and 8 years of directly related experience
Mechanical Engineering / Chemistry / Biology.
Experience in qualification and validation, change control management.
In support of Client Quality Assurance program acts as the technical specialist. Review and approve product MP’s.
Approve process validation protocols and reports for mfg. Processes. Represent Quality on incident triage team.
Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents.
Represent QA on NPI team. Lead investigations. Own site quality program procedures. Designee for QA manager on local CCRB.
Doctorate degree and 2 years of directly related experience or Master’s degree and 6 years of directly related experience or Bachelor’s degree and 8 years of directly related experience or Associate’s degree and 10 years of directly related experience.
COMPETENCIES/SKILLS 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 processes development. Demonstrated 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 Client Values/Leadership Practices.