Weekend Quality Control Senior Specialist

WuXi Biologics; Cranbury Township (NJ); On-site; USD 39,000 - 58,000; Full time

Job summary

WuXi Biologics is seeking a Senior Assocaite Specialist, Quality Control (Weekend) in Cranbury, NJ. The role focuses on on-time sampling and testing for QC, including EM sampling, water and gas sampling, and raw material checks.

The Weekend shift spans 8:30am–5pm with Saturday & Sunday requirements and three weekdays. Strong GMP documentation, data reporting, and communication skills are essential.

Qualifications

• Experience with GMP laboratory operations and documentation.
• Familiarity with environmental sampling and cleanroom procedures.
• Proficiency in data entry, trend analysis, and report generation.

Responsibilities

• Adhere to GMP sampling and testing in accordance with SOPs.
• Follow EM sampling in cleanroom areas across Cranbury or US sites.
• Support sample receiving, transporting, and inventory management as needed.
• Perform micro testing (bioburden, pH, endotoxin, TOC, etc.).
• Input data and generate EM data trend charts and reports.
• Investigate OOS/OOL/Atypical results and initiate CAPA as needed.
• Assist in preparing reports, deviations, and validation documents.

Skills

cGMP

ICH

QA/QC

EMS sampling

Education

High School diploma or equivalent

Bachelor's degree in Chemistry/Biology or related

Master's degree not required

Tools

LIMS

Empower

TrackWise

Master Control

Job description

WuXi Biologics is seeking a Senior Assocaite Specialist, Quality Control (Weekend) in Cranbury, NJ. The role focuses on on-time sampling and testing for QC, including EM sampling, water and gas sampling, and raw material checks.

The Weekend shift spans 8:30am–5pm with Saturday & Sunday requirements and three weekdays. Strong GMP documentation, data reporting, and communication skills are essential.