Graduate Analyst Program – Operations
BNY
Quality Operations Specialist I – 12-hour Rotating Shift
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Office
Location: Singapore • 🇸🇬 Singapore
Visit company websiteJob Level
Junior
Tech Stack
TFS
About the role
- Follow site safety requirements and maintain safe working conditions during daily operations
- Serve as a Quality representative on the manufacturing floor, resolving issues and ensuring compliance in real-time
- Draft and review quality operational procedures and support cross-functional SOP development
- Coordinate compliance activities on the shop floor and proactively identify and address quality concerns
- Collect firsthand shop floor information and collaborate with operations teams to solve problems
- Perform Quality Monitoring for aseptic manufacturing steps
- Conduct Acceptable Quality Checks for sterile products
- Coordinate microbiology quality for vial reading of incubated media-filled vials
- Support QC area by reviewing QC documents
- Participate in site operational readiness programs, including self-inspection and data integrity surveillance
- Review and approve Master Batch Records and Master Formulation Records to ensure compliance with TFS quality standards and cGMP requirements
- Assist QA manager with batch disposition
- Review and approve validation documents, including computer system validation
- Maintain site readiness for GMP and client audits
- Lead or participate in deviation and OOS investigations to determine root causes and implement effective CAPAs
- Review and approve relevant procedures to ensure compliance with cGMP and TFS quality standards
- Support regulatory inspections and client audits to ensure effective management of QA operations areas
- To support shift work when required
Requirements
- Bachelor's degree in Life Sciences, Chemical Engineering, Biochemical Engineering, or a related scientific field of study
- 1 to 3 years of experience in pharmaceutical or biopharmaceutical quality operations is preferred
- Fresh graduates with strong academic backgrounds in relevant fields are welcome to apply
- Exposure to Quality Management Systems and biologics manufacturing will be an added advantage
- Solid understanding of cGMP and regulatory compliance standards
- Strong attention to detail and effective communication skills
- Ability to coordinate multi-functional teams and drive collaboration
- Analytical perspective with a proactive approach to solving quality issues
- Familiarity with quality risk management tools is beneficial
Benefits
- competitive remuneration
- annual incentive plan bonus
- healthcare
- a range of employee benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality MonitoringAcceptable Quality ChecksMaster Batch RecordsMaster Formulation Recordscomputer system validationdeviation investigationsOOS investigationsCAPAsQuality Management Systemsbiologics manufacturing
Soft skills
attention to detaileffective communicationcoordinationcollaborationanalytical perspectiveproactive problem solving
