Senior Scientist, Quality Control CQV

Job Title - Senior Scientist, Quality Control CQV

Work Location - Cranbuy NJ

Job Responsibilities:

• Lead, manage and support the QC CQV team in accordance with cGMP requirements.
• Responsible for QC CQV daily operation and management to comply with GMP, results delivery, data reliability and occupational safety protection requirements.
• Organize and ensure the execution of calibration plan and execution of preventive maintenance (PM) for instruments/pipettes and review related records.
• Contact vendor or Facilities and Engineering department (F&E) to schedule onsite maintenance or repair for instruments. Ensure the execution of maintenance and review related records
• Organize and ensure the execution of periodic review (PRE) plans for instruments and review related records
• Responsible for or coordinate to complete the qualification of instruments/equipment/systems and review the related documents.
• Responsible for or coordinate the completion of software validation for analytical instrument software, including but not limited to 32Karat, SoloVPE software, and EndoScan-V.
• Ensure the systems are managed/maintained following system management/maintenance procedures within the analytical instrument/equipment life-cycle, including but not limited to user account management, system configuration and audit trail management.
• Participate in and support department driven projects towards internal company continuous improvement initiatives to promote a high productivity culture.
• May participate in clients’ audits, regulatory audits and internal and external inspections. Ensure department compliance metrics are well controlled to adhere to the QA Quality council and Quality Management review metrics.
• Participate in Quality Control system improvement initiatives and support the integration of WBS (Wuxi Business System) concepts and mechanisms into the SG QC daily operations. Initiatives such as managing the GEMBA process, Tier 1 accountability board review, editing/approving QC SOPs, designing and advising systems functionality (LIMS, ELN, SAP etc.), assisting the internal QC compliance team.
• Any other duties assigned by the supervisor (when applicable).

Below are job responsibilities of Lab Admin role:

• Lead various QC computerized system requirement, design, ensure GAMP adherence qualification, implementation and routine operation including participating cross sites’ alignment/optimization initiatives.
• Ensure the systems are managed/maintained following system management/maintenance procedures within the system life-cycle and perform review when necessary.
• Responsible for assisting validation or IT department to complete system qualification, and review the qualification documents, such as validation plan, URS, risk assessment, validation protocol, validation report, etc.
• Daily maintenance of LIMS system and/or other computerized systems, including but not limited to static data configuration, functional requirements improvement and testing, problem handling, user training, etc., to meet the daily operation requirements of the system.
• Continuous improvement of efficiency of LIMS system and/or other computerized systems.
• Daily maintenance of Empower and other instrument software, including but not limited to project creation, management of user account, data storage, backup, restore, and archiving (if needed).
• Coordinate with the validation department to complete the design and qualification of the Excel spreadsheet, write and review the qualification documents.
• Lead and ensure the periodic data integrity self-check of QC instrument software or systems in a scheduled manner.

Qualifications:

• Full-time undergraduate degree or above, majoring in biology, chemical engineering, chemistry, pharmacy or related majors.
• Bachelor's degree: at least 9-11years of experience in the professional field.
• Master's degree: at least 7-9 years of experience in the professional field.
• PhD: at least 2-4 years of experience in the professional field.
• Experience in quality control laboratory or in a GMP environment
• Familiar with Computerized System related regulatory, such as CFR21 Part11, EU GMP Annex 11, etc.
• Familiar with analytical instrument/equipment qualification, calibration, PM and repair, such as UPLC, HPLC, CE and CIEF etc,
• Familiar with ALCOA+ principles.

Preferred capabilities:

• Experience in analytical instrument/equipment operation and sample testing.
• Familiar with handling deviations, change control, and responding to audit questions
• People leadership skills

Following capabiliites are preferred for Lab Admin role:

• Familiar with the operation of instrument software, including but not limited to Empower, SoftMax Pro, 32Karat, EndoScan-V, LabX.
• Experience in Laboratory Information Management System (LIMS), CisPro chemical and material inventory management system , and Laboratory Execution System (LES).

The anticipated salary range for this position is $73,000 - $116,000.

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. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation and gender.