Job Title

• QC Senior Scientist
• Micro/RM/Compendial Testing and Sampling Work Location
• Cranbury, NJ Job Summary The QC Micro/RM/Compendial Senior Scientist is responsible for the quality and on-time completion of microbiology/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 Functions Understand GMP and follow instructions on the documents. Perform microbiology/raw material/compendial testing including but not limited to FTIR, pH, Color, Clarity, visible and subvisible particles, osmolarity, bioburden, endotoxin, CCIT, etc. Able to follow and conduct EM/water/gas sampling in cleanroom areas in/between the various building sites in Cranbury or other US sites (when needed). Need to support RM sample sampling and its transporting needs in/between the various building sites in Cranbury or other US sites (when needed). Management of raw material, EM monitoring 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 or incubation of EM samples are under conducted properly and within control (when needed) Support reagents/consumables inventory management to ensure consistent QC EM operation needs. 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/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).

As Subject Matter Expert:

Generate documents such as SOPs, analytical methods, and On The Job training and trains junior staff on methods. Optimize methods to improve efficiency while adhering to Quality Control standards. Troubleshoot any issues on assays, instruments, or reagents. Investigate any OOS/OOT and atypical results and laboratory investigations, conduct root cause analysis, and implement CAPA. Attend internal and external meetings and present data summary, investigation results, or trending analysis to project teams or clients. Proactively respond to and participate in scheduled audits and able to defend methodologies to auditors. Job Requirement Technical Skills /

Knowledge:

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 (eg. 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

Problem Solving:

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 .

Communication Skills:

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.

Education and Experience:

Full-time undergraduate degree or above, majoring in biology, chemical engineering, chemistry, pharmacy or related majors. Bachelor's degree: 9+ years of experience in the professional field Master's degree: 7+ years of experience in the professional field

PhD:

2+ years of experience in the professional field The anticipated salary range for this position is $54,700 to $87,500 Job description does not intend to list all the duties and responsibilities assigned to this position. Employees holding this position are required to perform other job-related duties/responsibilities based on their expertise and company business needs. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability