Sr Specialist QA

In support of 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.

Requirements: The candidate should have experience in Commissioning and Qualification, Equipment validation, QRAES, Kneat, Good Documentation Practices, Change Controls, SOP’s etc

Job Type: Full-time

Pay: From $50.00 per hour

Education:

• Bachelor's (Preferred)

Experience:

• Specialist QA: 8 years (Preferred)
• inspection and packaging processes validation: 8 years (Preferred)
• medical devices: 8 years (Preferred)

Work Location: In person