About the role
AI summarisedMid-level QC Associate/Senior QC Associate performing analytical testing and quality control support for pharmaceutical manufacturing in Singapore. Role involves routine and non-routine testing, method validation, equipment maintenance, compliance with cGMP/cGLP/cGDP, and continuous improvement initiatives.
BiopharmaOnsiteQuality
Key Responsibilities
- Perform peer reviews and support method verification, validation and transfers as required
- Manage sample receipt, triage, storage (sample integrity), chain of custody and disposition to ensure traceability
- Maintain inventory control of reagents, consumables and prepared materials (use Kanban principles to avoid stockouts/overstock)
- Act as SME during audits and ensure inspection readiness
- Follow EHS policies; ensure correct waste disposal and laboratory housekeeping
- Perform periodic review and revision of laboratory SOPs, OJTs, Working Risk Assessment (WRA), Chemical Risk Assessment (CRA) and associated documents as assigned
- Ensure timely turnaround of results and adherence to schedules and quality metrics. Escalate issues in a timely manner
- Promptly identify, report and support investigations into invalid/OOS/atypical results and equipment failures; contribute to CAPA closure
- Operate, calibrate, troubleshoot and arrange maintenance/repairs for laboratory equipment; raise work requests and liaise with vendors
- Execute tests right-first-time with accurate, complete documentation in line with ALCOA+, cGMP, cGLP and cGDP requirements
- Maintain competency through required training and deliver training to new hires or team members (senior/lead)
Requirements
- Diploma or degree in Chemistry, Biology, Biochemistry, Biotechnology or a related life science field
- Minimum of 2 years laboratory experience in an analytical environment
- Practical knowledge of good laboratory practices and good documentation practices
- Clear written and spoken English with accurate documentation skills
- Experience in chemistry testing techniques or biochemical assays
- Sound knowledge of cGMP, cGLP, cGDP and laboratory safety
- Good organisational, communication and teamwork skills
- Familiarity with laboratory information systems, LIMS or electronic data management
- Experience leading investigations, CAPA and continuous improvement activities
- Knowledge of equipment qualification, calibration and validation processes
- Ability to train others, and problem-solving skills
- Proficiency with Excel and basic data analysis for trending and reporting