Specialist QA 35619

Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities.

• Experienced working in biopharmaveutical industry
• Quality organization supporting deviations, validation reports, qualifications, investigations
• At least 5 years of experienced in a highly regulated environment .
• Technical Writing
• Technical Documents review and approval (Reports, Technical reports, Procedures, Forms) of process and cleaning validation.

Functions:

• 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.
• Perform investigations and 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.
• Approve NC investigations and CAPA records.
• Approve change controls.
  
  

• Doctorate OR Masters + 2 years of directly related experience OR Bachelors + 4 years of directly related experience OR Associates + 8 years of directly related experience OR High school/GED + 10 years of directly related experience.