Sr Specialist QA

SUMMARY
In support of Client's Quality Assurance program acts as the technical specialist. Review and approve product MPs.

FUNCTIONS

• 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.

EDUCATION/LICENSES

• 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 or High school diploma / GED and 12 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.

Weil Group is proud to be an Equal Employment Opportunity Employer.