Senior QC Specialist (Biotechnology)

About This Role

This senior quality control specialist role in biotechnology supports the daily QC operations, ensuring products meet standards at every manufacturing stage. The position involves inspecting raw materials, intermediates, in-process materials, and finished goods, as well as investigating nonconforming products. It suits a candidate with strong QC experience in a regulated environment.

Responsibilities

• Manage team performance, including training, competency assessments, and ensuring the technical proficiency of QC staff
• Supervise QC Specialists and Technicians to ensure smooth execution of routine QC operations
• Plan and schedule daily QC routine and ad hoc testing
• Oversee QC lab housekeeping, including cleanliness, equipment maintenance, document archival, and reagent inventory tracking
• Perform routine QC testing of raw materials, in-process materials, and finished goods
• Evaluate data, draft and/or review QC reports, highlighting deviations from standard operating procedures
• Perform trend analysis and utilize Statistical Process Control (SPC) tools to identify process anomalies and prevent failures
• Troubleshoot QC failures and raise nonconformance reports when needed
• Investigate nonconformances to determine root causes
• Support validation and stability studies for lab development and diagnostic products as needed
• Ensure all laboratory activities and documentation are compliant with ISO13485 and relevant regulatory requirements
• Draft and update QC work instructions and contribute to the continuous improvement of workflow procedures and processes
• Apply good documentation practices on all records for better traceability, transparency, and the purpose of auditing
• Perform any other duties as assigned

Requirements

• Diploma/Bachelor/Master of Science/Engineering or equivalent in Biotechnology, Biochemical, Biochemistry, Analytical Chemistry, Molecular Biology/Life Science related courses
• qPCR knowledge and experience in using qPCR machine
• Familiar with basic laboratory procedures
• Able to work independently with minimal supervision and with others within and outside his/her function
• Excellent organizational and time management skills
• High degree of initiative and ownership
• Possess a positive and willing-to-learn attitude
• Good logical thinking and reasoning ability
• Good Documentation Practices and ability to write protocols and procedures
• 4-5 years of relevant experience in quality control

Nice to have:

• Relevant experience with laboratory testing and QC of assays-based workflow