Senior QA Specialist - Biopharma GMP & Client QA

WuXi Biologics Group; New Jersey; Hybrid; USD 72,000 - 116,000; Full time

Job summary

WuXi Biologics Group in New Jersey is seeking an experienced QA/QC professional to lead quality activities in a biopharmaceutical facility. You will collaborate with Manufacturing Operations, Quality Control, MSAT, and Engineering to resolve issues and ensure GMP standards are met.

The ideal candidate holds a Bachelor/Master/PhD in Biochemistry or related science with 8+ years in QC/QA, plus familiarity with TrackWise and MasterControl.

Qualifications

• 8+ years of QC/QA experience in a biopharmaceutical facility.
• Knowledge of FDA/EMA regulations, ICH and cGMP guidelines is a plus.
• Good oral and written communication skills in English.

Responsibilities

• Build and maintain relationships with cross-functional teams to resolve quality issues.
• Ensure compliance with SOPs and production requirements.
• Support client PIP and client QA during client visits.
• Attend regular department/global/client meetings as required.
• Seek management guidance on complex issues.

Education

Bachelor/Master/PhD in Biochemistry or related science

Tools

TrackWise

MasterControl

Job description

WuXi Biologics Group in New Jersey is seeking an experienced QA/QC professional to lead quality activities in a biopharmaceutical facility. You will collaborate with Manufacturing Operations, Quality Control, MSAT, and Engineering to resolve issues and ensure GMP standards are met.

The ideal candidate holds a Bachelor/Master/PhD in Biochemistry or related science with 8+ years in QC/QA, plus familiarity with TrackWise and MasterControl.