Quality Operation Specialist
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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:
- Bachelors 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.
Required Experience:
IC
Key Skills
- Computer Science
- Business Process
- SQL
- Active Directory
- VMware
- Data Entry
- Clearance
- OS
- Windows
- System Issues
- Linux
- Sharepoint
- Backup
- hardware
- Technical Support
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
