Quality Assurance Specialist II

Description

JOB SUMMARY:

• The Quality Assurance Specialist II is an intermediate level position with hands-on QA and QC experience.
• Under moderate supervision, the individual will be working primarily on quality systems within the Product Quality Assurance group to support QC and AD related processes specifically method validation projects.

ESSENTIAL DUTIES:

• Perform QA review for AD method validations projects.
• Perform QA review for QC related quality system records including deviation, CAPAs, Change Controls, and OOTs.
• Assist in QA review of QC related equipment and process validations.
• Perform a wide variety of quality assurance activities to ensure compliance with Client procedures, applicable US and international regulatory requirements for biologic drug substances and drug products under clinical development.
• Review, approve, and track closure of the change controls, deviations, quality investigations and CAPAs.

Skills:

• Experience within QA and QC/AD departments.
• Candidates with only QC/AD experience will be considered.
• Minimum 4 year’s experience performing quality functions in pharmaceutical and/or biotech related fields.
• Working knowledge of quality systems cGMP standards applicable to biologics DS and DP.

Education:

• BS or equivalent in biology, chemistry or related science or equivalent experience.