Quality Control Specialist (Weekend)

About the role

The QC Specialist (Weekend Shift) is responsible for the quality and on-time testing and collection of samples, environmental monitoring (EM), water and gas system sampling (when required), and raw material sampling. This role ensures QC deliverables to internal departments and external clients are accurate and consistent, while demonstrating strong oral and written communication skills. The position actively contributes to training, report generation, and GMP documentation.

Responsibilities

• Adhere to GMP sampling (clean rooms, WFI, gas) and testing, following laboratory procedures in compliance with cGMP guidelines and internal SOPs.
• Conduct EM sampling in cleanroom areas across various building sites in Cranbury or other US sites (when needed).
• Support sample receiving and transporting needs between building sites in Cranbury or other US sites (when needed).
• Perform microbiology-related testing, including but not limited to bioburden, pH, growth promotion, endotoxin, conductivity, TOC, nitrate, plate readings, and plate transferring (when required).
• Receive samples, perform testing, and report results independently and in a timely manner.
• Input data and generate EM data trend charts and reports.
• Initiate investigations or excursions for Out-of-Specification (OOS), Out-of-Limit (OOL), or atypical results.
• Manage reagents and consumables inventory (LIMS receiving, disposal) to ensure consistent QC Micro operation needs.
• Operate according to experimental or sampling plans, methods, and SOPs.
• Record and organize experimental data in accordance with "Good Document Management Practices" to ensure data integrity.
• Ensure compliance with training, preparation, documentation, and general lab maintenance requirements for industry standards and regulations.
• Assist in preparing SOPs, protocols, final reports, investigations, and deviations as needed.
• Investigate Out-of-Specification results and laboratory deviations, conduct root cause analysis, and implement CAPA.
• Assist in preparing or executing validation documents to support new materials, process changes, and qualifications.
• Maintain laboratory notebooks and worksheets for QC tasks as required.
• Work weekend shifts (Wed–Mon or Thur–Tue).
• Support night shift work when required by supervisor.
• Perform any other duties assigned by the supervisor.

Requirements

• High school certificate or above, and/or advanced degree in Chemistry, Microbiology, Biochemistry, or equivalent field.
• Preferred experience:
  • High school certificate: 2+ years of working experience.
  • Bachelor’s degree: 1+ years of working experience.
  • Master’s degree: no experience requirement.
• Willingness to learn analytical and QC operations in the pharmaceutical industry, with an understanding of current regulations and industry trends (e.g., cGMP, ICH, EMA, FDA, and other global compendia).
• Basic familiarity with analytical instruments and methodologies (e.g., TOC, conductivity meter) is preferred but not mandatory.
• 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.
• Basic experience in planning and solving simple QC technical and operational problems.
• Ability to raise issues immediately to supervisors and seek guidance when needed.

Skills

• Proficiency in English with strong verbal, written, and presentation skills.
• Effective communication and collaboration with colleagues.

Pay

The anticipated salary range for this position is $60,200 to $96,300.

Schedule

• Weekend shift: Wed–Mon or Thur–Tue.
• Night shift support may be required as needed.