The following job description applies to the position, department and business unit as stated below:
Job Title
QC Senior Scientist (SME) – Microbiology Testing
Location
New Jersey, USA
Site/Department
Cranbury MFG 18/QC
Business Unit or Division
WuXi Biologics Development
Line Manager
QC Manager, MFG18
Job Summary
The QC Micro Senior Scientist is responsible for the quality and on-time completion of micro tests, microbiology laboratory inventory management to the various testing sections. 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 micro related testing including but not limit to bioburden, pH, growth promotion, endotoxin, conductivity, TOC, nitrate, 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 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).
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, instrument, 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 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.