Associate Scientist, QC

WuXi Biologics; Cranbury Township (NJ); On-site; USD 50,000 - 80,000; Full time

Job summary

WuXi Biologics in Cranbury, NJ, seeks an Associate Scientist, QC to manage QC documentation, track COA and stability reports, and support sample management to ensure on-time delivery of test results and data. Strong communication and time-management skills are required for efficient operation and collaboration with internal and external clients.

The role requires a Bachelor or advanced degree in biology or a related field, with QC/GMP experience considered a plus.

Qualifications

• Bachelor or advanced Graduate degree in Biology, Cell Biology, or equivalent field.
• Experience in QC/GMP environment is a plus.

Responsibilities

• Track COA for release batches and stability data.
• Archive and manage controlled records and data.
• Support sample receiving, aliquoting, storage and distribution.
• Support QC lab inventory with paper forms or LIMS module.

Skills

Project management

Critical thinking

Communication

Multitasking

Time management

Problem solving

Data handling

Education

Bachelor or advanced Graduate degree in Biology

Tools

LIMS

Data analysis tools

Job description

Job Title – Associate Scientist, QC

Work Location – Cranbury, NJ

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. WuXi Biologics’ achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies

Job Summary

The QC Associate Scientist is responsible for QC document tracking, tracking COA and stability reports, archival, reconciliation of controlled documents and support sample management to support QC GMP activities, including but not limited to in-time and properly sample receiving, aliquoting, storage, and distribution for testing to support on-time delivery of test results, validation data and other QC deliverables to internal and external clients. Strong communication and time management skills are desired.

Essential Job Functions

• Responsible for tracking COA of release batches.
• Responsible for track the testing progress of stability batches and the issuance of data summary.
• Responsible for tracking and archiving of controlled records.
• Responsible for scheduling and updating information for immediate testing for product testing group.
• Responsible for scheduling and updating information for immediate testing for product testing group.
• Support laboratory operations for product testing group.
• Support QC sample management, reference standard management, and stability sample management, including but not limited to receiving, aliquoting, distributing, tracking, and disposing of QC testing samples/stability samples.
• Support QC lab inventory management, including but not limited to QC lab inventory ordering, receiving, storage, distribution, inventory tracking by using either paper-based forms or LIMS inventory module, and generating inventory-related monthly report.
• Proactively search for opportunities to improve efficiency, quality and technical excellence.
• Complete training activities in time in MC.

Experience / Education

• Bachelor or advanced Graduate degree in Biology, Cell Biology, or equivalent field.
• Experience in QC/GMP environment is a plus.

Knowledge / Skills / Abilities

• Knowledge and expertise in project management tool or other data analysis tool is a plus.
• Critical thinking, fast learner, scientific reasoning and problem solving skills.
• Good project management, time management, communication and multitasking skills.
• Good computer operation skills.

The anticipated salary range for this position is $49,700 to $79,500

WuXi Biologics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability