Quality Specialist II

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 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, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 90,000 colleagues 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 and Patheon. For more information, please visit www.thermofisher.com.

Quality System Specialist Il is accountable and responsible for supporting the Batch records issuance, Work order verification for accuracy, Batch records issuance per applicable process, 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.

• Responsible for the Finished Good Labelling System: creation revision and control of the finished product label including Label design, Graphic Creation, Documentation routing in Agile (Graphic and its applicable Finished Good Specification), Creation of Master File (per applicable packaging area)
• Provide On-the-Job training (OJT) as its related to Training in Bartender application to all colleagues.
• Provides quality support for new product introductions and supports Miami projects as they relate to labelling design.
• Directly support incoming raw material documentation.
• Quality Systems Specialist Il is 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.2. 10. Maintain and monitors site compliance with applicable regulations to the site: ISO 9001 or applicable regulatory standard and any transition to any update requirements.
• Performs other duties, projects, as assigned.

Physical and Environmental Requirements:

• Must be able to work safely with materials and equipment.
• Expose to fumes and chemicals such as raw materials, cleaners, etc.
• Must be able to work overtime and flexible shifts.
• Various levels of gowning are required.

Knowledge and Experience

• Bachelor's Degree in Life Sciences or Engineering.
• Minimum 3 - 5 of experience in Pharma related / Quality Systems
• Knowledge and Experience of Quality Systems, specifically ISO 9001:2008 and 21 CFR Part 820, 210 or 211.
• Good understanding of Good Manufacturing Process including manufacturing, packaging process, aseptic and sterile fill process and systems.
• Strong in application of technical principles, practices and procedures.
• Experience on Quality Systems computer applications: Trackwise, and Electronic Documentation Systems.
• Experience in material releases using Quality Management Systems application: Inventory Management, Laboratory Information Management System (LIMS) or similar applications.
• Experience in regulated manufacturing, clean room, and gowning requirements.
• Basic to intermediate proficiency in Microsoft Office.

Skills

• Effective communication skills at all levels both written and verbal.
• Worked in a fast-paced manufacturing facility with shifting priorities
• Ability to work in teams to obtain results, self-motivated/directed, ability to organize activities, minimal supervision required.
• Effective skills in analytical thinking and problem solving.
• Teamwork and Collaboration skills.
• Models personal discipline, accountability, integrity, and operational excellence.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.