Senior Associate Scientist, Quality Control

Job Responsibilities

• Understand GMP and follow instructions on the documents.
• Perform raw material/compendial testing including but not limited 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.
• Absorb and execute validation documents to support new materials, process changes and qualifications.
• Maintain laboratory notebooks and worksheets for QC tasks as required.
• Able to work at weekend when needed.
• Able to work shift 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
• No requirement for PhD
• 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.

Pay

The anticipated pay range for this position is $54,000 - $87,000