Quality Control, Senior Associate Specialist (Weekend)

Job Summary

This team member (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.

Job 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.
• Absolutely ensure compliance to training, preparation, documentation and general lab maintenance requirements for Industry Standards and/or Regulations.
• Absolutely assist in preparing SOP, protocols, final reports, investigations, and deviations as needed.
• Absolutely assist in investigating any Out-of-Specification results and laboratory deviations, conducting root cause analysis, and implementing CAPA.
• Absolutely 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.
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue) and night shift work when required by supervisor (when needed).
• Supports weekend shift (Wed to Mon, or Thur to Tue