Job Opportunity

Job Opportunity

Associate Scientist, QC Testing - Raw Materials & Compendial

Associate Scientist, QC Testing - Raw Materials & Compendial

United States Posted 2024-07-17

Associate Scientist – QC Sampler - Raw Materials & Compendial/EM

WuXi Biologics is a 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 Sampler Scientist is responsible for the quality and on-time delivery of samples, EM (Environmental sampling), laboratory inventory management to the various testing sections. This role will also ensure QC deliverables to internal departments and external clients are accurate and consistent. Demonstrates strong oral and written communication skills and actively contributes to training, report generation and GMP documentation.

Responsibilities:

Adhere to GMP sampling (raw material/EM monitoring) and follow laboratory procedures according to and in compliance with cGMP guidelines and internal SOPs.
Able and comfortable in lifting 30-50 pounds of materials in daily sampling operations within cleanroom areas.
Able to follow and conduct EM sampling in cleanroom areas in/between the various building sites in Cranbury or other US sites (when needed).
Need to support QC sampling and sample transporting needs in/between the various building sites in Cranbury or other US sites (when needed).
Management of raw material, EM monitoring samples, raw material sampling room, sample storage room and regulatory retain sample room, etc., and ensuring the sampling process and storage of raw material samples or incubation of EM samples are under conducted properly and within control.
Support auxiliary solutions preparation for GMP testing according to related sampling plan test specifications. Support daily solutions/reagents/consumables inventory management to ensure consistent QC RM operation needs.
Operate according to the experimental or sampling plan and deliver results, testing/sampling method/SOP's
Record and organize experimental data in accordance with "Good Document Management Practices" to ensure data integrity.
Ensure compliance to training, preparation, documentation, and general lab maintenance requirements for Industry Standards and/or Regulations.
Assist in preparing SOP, protocols, final reports, investigations, and deviations as needed.
Assist in investigating any Out-of-Specification results and laboratory deviations, conducting root cause analysis, and implementing CAPA.
Assist in preparing or executing validation documents to support new materials, process changes, and qualifications.
Maintains laboratory notebooks and worksheets for QC tasks as required;
Any other duties assigned by the supervisor (when applicable).

Technical Skills / Knowledge:

Candidate must possess a willingness to learn analytical and QC operations of the pharmaceutical industry and understand current regulations and industry trends of biologics product development, characterization, and manufacturing testing requirements including cGMP, ICH, EMA, FDA, and other global compendia regulations and guidance.
Ability to use basic laboratory equipment with no difficulties.
Basic familiarity with analytical instruments and methodologies, such as HPLC, Densitometer, Colorimeter, Turbidimeter, HIAC/Subvisible particles, FTIR, pH, Karl Fisher, and/or potentiometric titration is preferred but not mandatory.
Basic experience with software and information systems (e.g. Empower, TrackWise, Master Control, and preferably LIMS). Ability to adapt between strategic and tactical thinking/planning and manage multiple priorities to achieve department and site objectives.
Ability to understand technical data

Problem Solving:

Basic experience in planning and ability to solve simple QC technical and operation problems.
Be able to raise issues immediately to supervisor and work with supervisor when in doubt.

Communication Skills:

Proficiency in English is required. Good communication skills (verbal, written, and presentation skills).
Effectively exchange information or discuss clearly framed issues or ideas with colleagues.

Qualifications:

High school certificate or above degree and/or advanced Graduate degree in Chemistry, Microbiology, Biochemistry or equivalent field.
High school certificate: <1 year and above working experience is preferred
Bachelor's degree: 1+ years of experience in the professional field
Master's degree: no requirement

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

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