Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Quality Specialist I. is responsible for supporting the Batch records issuance per applicable process, work order verification for accuracy, manufacturing control card issuance or weighing automated system application and finished good label file creation. Models our 4i values, integrity. Innovation, intensity, and involvement. Complies with our Quality Policy by continuously improving the quality of our products & services and by ensuring global regulatory compliance.
Essential Functions:
- Provide On-the-Job training (OJT) as its related to Training in Bartender application to all colleagues.
- Directly support incoming raw material documentation.
- Accountable and responsible for the overall material release, and disposition "End to End" (E2E), ensure all investigations related to materials are completed following Quality Systems.
- Support the quality monitoring and release of all raw materials and products linked to GMP Pilot, Work Order and New Product Introduction.
- Revise Standard Operating Procedures (SOPs) as needed to support batch record readiness and quality related functions as applicable.
- Effectively support manufacturing as a QA specialist to properly perform Real Time Batch Record Review and final batch records review and material disposition.
- Maintain and monitor site compliance with applicable regulations to the site: ISO 9001 or applicable regulatory standard and any transition to any update requirements.
- Perform all job duties within ISO standards, regulatory or statutory requirements.
- Performs other duties, projects, as assigned.
Knowledge and Experience
- Bachelor’s degree in Life Sciences or Engineering and Minimum 3 – 5 years’ experience in Pharma related / Quality Systems
- Knowledge of cGMPs , TrackWise, Laboratory Information Management Systems (LIMS), E1 and Oracle,
- Knowledge in standards and regulations such as ISO 9001, specifically ISO 9001:2008 and 21 CFR Part 820, 210 or 211.
- Experience in regulated manufacturing, clean room and gowning requirements.
- Strong written and oral communication skills
- Must be able to communicate effectively with multiple levels of staff throughout the organization.
Top Skills
What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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