Scientist I, Quality Control

Job Title - Scientist l, Quality Control - RM/Compendial Testiing and Sampling

Work Location - Cranbury NJ

Job Summary

The QC RM/Compendial Scientist is responsible for the quality and on-time completion of raw material/compendial testing and sampling. This role will also ensure QC deliverables to internal departments and external clients are accurate and consistent. Demonstrates good oral and written communication skills and actively contributes to timely training, report generation and good GMP documentation and archival.

Job Responsibilities

• Understand GMP and follow instructions on the documents.
• Perform raw material/compendial testing including but not limit to FTIR, pH, Color, Clarity, visible and subvisible particles, osmolarity, etc.
• Able to support Raw Material sample sampling and its transporting needs in/between the various building sites in Cranbury or other US sites (when needed).
• Management of raw material 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 are conducted properly and within control.
• Support reagents/consumables inventory management to ensure consistent QC RM/Compendial operation needs.
• 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 or executing validation documents to support new materials, process changes and qualifications.
• Maintains laboratory notebooks and worksheets for QC tasks as required.
• Able to work at weekend when needed.
• Support shift work when needed.
• Any other duties assigned by the supervisor (when applicable).
  
  
  
  

Qualifications

• Full-time undergraduate degree or above, majoring in biology, chemical engineering, chemistry, pharmacy or related majors.
• Bachelor's degree: 6 years of experience in the professional field
• Master's degree: 4 years of experience in the professional field
• PhD: 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 pH, turbidity meter, HIAC, etc, is preferred.
• Basic experience with software and information systems (eg. TrackWise, Master Control, 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
• Experience in planning and ability to solve 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.
  
  
  
  

The anticipated pay range for this position is $60,000 - $95,000

The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.