The Quality Operations Specialist will ensure compliance with GMP standards, support QA in manufacturing, conduct quality checks, and assist in audits.
Work Schedule
12 hr shift/daysEnvironmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
Position Summary
Join Thermo Fisher Scientific Inc. as a Quality Ops Specialist for impactful work.
Responsibilities
- Follow site safety requirements and maintain safe working conditions during daily operations.
- Quality on the floor: shop floor QA performer and problem solver.
- Write all quality operational procedures and review SOPs from other functional teams.
- Provide QA support to manufacturing operations and coordinate routine shop floor compliance.
- 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.
Minimum Requirements/Qualifications
Education:
- Bachelor’s Degree in Life Sciences, Chemical/Biochemical Engineering, or a related scientific area with equivalent experience.
Experience:
- 1-3 years of relevant quality experience in pharmaceuticals preferred. Fresh graduates with relevant qualifications may also be considered.
- Experience in Quality Management Systems and biologics is an asset.
Proficiencies:
- Knowledge of cGMP, Regulatory Compliance, and GMP Quality Management Systems.
- Strong detailed thinking and communication skills.
- Effective coordination and collaboration abilities.
- Proven problem-solving skills and knowledge of Quality Risk Management tools.
Top Skills
Cgmp
Quality Management Systems
Similar Jobs
Cloud • Information Technology • Security • Software • Cybersecurity
The Incident Response Manager leads the Security Response Team, overseeing security operations, optimizing incident response processes, and collaborating with cross-functional teams to enhance security posture.
Top Skills:
AWSAzureEdrGCPGoPythonRubySIEMSoarSQL
Productivity • Software • App development • Automation
The Account Executive will manage sales leads for software solutions, work closely with technical teams, and develop client relationships.
Top Skills:
Salesforce CRM
Productivity • Software • App development • Automation
The Strategic Account Manager will drive business growth by managing high-value accounts, expanding relationships, and identifying new sales opportunities.
Top Skills:
DoolyOutreachSales NavigatorSalesforceZoominfo
What you need to know about the Singapore Tech Scene
The digital revolution has driven a constant demand for tech professionals across industries like software development, data analytics and cybersecurity. In Singapore, one of the largest cities in Southeast Asia, the demand for tech talent is so high that the government continues to invest millions into programs designed to develop a talent pipeline directly from universities while also scaling efforts in pre-employment training and mid-career upskilling to expand and elevate its workforce.
