Quality Control Specialist (Weekend) (5153)

WuXi Biologics•Cranbury, NJ

45d•Onsite

About The Position

The QC senior specialist (Weekend Shift) is responsible for the quality and on-time testing/collection of samples, EM (Environmental sampling), Water and Gas system sampling (when required) with raw material sampling 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.

Requirements

High school certificate or above degree and/or advanced Graduate degree in Chemistry, Microbiology, Biochemistry or equivalent field.
High school certificate: 2 years and above working experience is preferred
Bachelor's degree: 1 year and above working experience is preferred
Master's degree: no requirement
Candidate must possess willingness to learn analytical and QC operations of pharmaceutical industry, understand current regulations and industry trends of biologics product development, characterization and manufacturing testing requirement including cGMP, ICH, EMA, FDA, and other global compendia regulations and guidance.
Basic familiarity with analytical instruments and methodologies, such as TOC, conductivity meter is preferred but not mandatory.
Basic experience with software and information systems (e.g. Empower, TrackWise, Master Control, LES, lab notebook 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
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.
Proficiency in English is required. Good communications skills (verbal, written, and presentation skills).
Effectively exchange information or discuss clearly framed issues or ideas with colleagues.

Responsibilities

Adhere to GMP sampling (Clean rooms, WFI, gas) and testing, follow laboratory procedures according to and in compliance with cGMP guidelines and internal SOPs.
Able to follow and conduct EM sampling in cleanroom areas in/between the various building sites in Cranbury or other US sites (when needed).
Able to support sample receiving, transporting needs in/between the various building sites in Cranbury or other US sites (when needed).
Perform micro related testing including but not limit to bioburden, pH, growth promotion, endotoxin, conductivity, TOC, nitrate, plate readings, plate transferring etc (when required).
Receive required samples, perform testing, report results independently and in a timely manner (when required).
Able to input data and generate EM data trend charts and reports.
Able to initiate investigation/excursions when having OOS/OOL/Atypical results.
Able to perform reagents/consumables inventory management (LIMS receiving, disposal etc) to ensure consistent QC Micro 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.
Support night shift work when required by supervisor (when needed)
Any other duties assigned by the supervisor (when applicable).