Quality Control Executive (Analytical)

CELLVEC PTE. LTD.; Singapore; On-site; SGD 40,000 - 70,000; Full time

Job summary

CELLVEC PTE. LTD. is seeking a qualified professional to manage product and raw materials testing in a biotech environment. The role involves developing analytical methods, conducting various QC tests, and ensuring compliance with regulatory standards. Candidates should possess expertise in analytical testing techniques, documentation practices, and be proactive in managing audits and deviations.

Qualifications

• Experience with method development for quality control.
• Strong background in analytical techniques and documentation standards.
• Ability to conduct investigations and handle quality deviations.

Responsibilities

• Develop and qualify methods for QC testing and perform analytical tests.
• Draft and review SOPs and technical protocols for lab procedures.
• Assist in audit preparations and manage laboratory equipment.

Skills

Analytical Testing

Flow Cytometry

qPCR Assay

Documentation Management

Audit Management

Job description

Product and Raw Materials Testing:

• Develop and qualify method of analysis (MOA) for QC lot release testing
• Perform analytical testing such as flow cytometry (FACS) and qPCR assay to support QC lot release.
• Perform stability testing of released final products as per protocol and timeline.
• Perform functional/comparability testing of raw materials such as plasmid, media, reagents and etc.
• Support assessment of certification/accreditation and services provided by external labs for QC lot release testing

Documents and Data Management

• Drafting and updating of relevant SOPs and specification documents for lab, equipment, test method, training and raw materials.
• Author and review technical protocols and test reports, develop guidelines and standard practices for data documentation and analysis.
• Review test results, document data and produce trends in an efficient, organised and presentable manner to facilitate discussions, and to support business and performance metrics reporting.

Deviations and Audit Management

• Assist OOS/test deviations initiation, investigations, root cause analysis and CAPA implementation for product defects and quality lapses.
• Support internal and external audits/inspections.

Equipment and Lab Management

• Monitor and schedule equipment calibration and maintenance as per schedule and site master file.
• Perform lab housekeeping, equipment, inventory, lab cleaning and biohazard/waste management.
• Perform monitoring and procurement of lab inventory, for e.g. materials and cosumables.

Continuous Improvement

• Implement initiatives to encourage improvement of QC procedures, activities and workflows.
• Conduct routine literature review through established publication channels to ensure continual knowledge proficiency on both GMP and current technological trends relevant to CellVec activities.