QA Specialist I

WuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing.

Responsibilities

• Perform On-The-Floor QA activities pertaining to Drug Substance Manufacturing Operations, including QA observation of Upstream (USP) and Downstream (DSP) processing, real time executed batch record review, corrections, logbook review, room clearance/changeover, and data integrity checks of electronic systems.
• Review, approve, and track executed production records; including client comment resolution.
• Review, approve, and manage deviations, investigations (ensure structured root cause analyses), develop scientifically justified CAPAs, change controls, and complaint records to ensure compliance with cGMP and data integrity expectations.
• Author, revise, and review controlled documents, including SOPs, batch records, protocols, reports, and risk assessments.
• Ensure compliance with applicable SOPs and production requirements.
• Provide QA support during internal audits, customer audits, and FDA inspections by preparing documentation and offering subject matter expertise.
• Support client PIP and client QA during Client visit.
• Attend regular department/global/client meetings as required or assigned.
• Routinely recognize and resolve Quality Issues on manufacturing floor.
• Seek management guidance on complex issues.
• Be the primary backup for Associate Director QA Manufacturing for DS Manufacturing.
• Perform duties as requested by management.
• Build and maintain relationships with cross-functional teams including Manufacturing Operations, Quality Control, MSAT, and Engineering to resolve issues to maintain quality standards.

Qualifications

• Bachelor, Master or PhD degree in Biochemistry or other related science discipline.
• 8+ years working experience in Drug Substance (DS) Manufacturing or QA in a Biopharmaceutical facility (hands on operational experience for DS manufacturing, either USP or DSP operations, will be highly considered over QA experience only).
• Knowledge of USP and DSP Manufacturing processes.
• Knowledge of facility system qualification is desired.
• Work is performed in a combination of 80% manufacturing cleanroom and 20% office environment.
• Work is generally performed in a clean-room environment generally seated but may require standing and walking for up to 50% of the time.
• Requires working shifts and weekends as needed.
• Knowledge of TrackWise and MasterControl is desired.
• Knowledge of FDA and EMA regulations, ICH and cGMP guidelines is a plus.
• Knowledge of Biopharmaceutical manufacturing is desired.
• Good oral and written communication skills in English.
• Good interpersonal communication skills, good organizational skills.

Pay

Salary range for this position is $72,800–$116,500.