Manufacturing Sterile Documentation Operator PDS

15 ago - Ferentino
Thermo Fisher Scientific

Work Schedule
Rotational M-F days
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
POSITION PURPOSE / RESPONSIBILITIES
Under the direction of the Department Supervisor, the incumbent performs the activities listed below,



for which they have been qualified through the required training, in compliance with company SOPs, current cGMP requirements, and EHS regulations.
KEY RESPONSIBILITIES
- Ensure the accurate execution and review of Sterile Manufacturing electronic Batch Records (eBRs) in accordance with current SOPs, cGMP requirements, and EHS standards.
- Verify the correct completion of batch records, work instructions, checklists, and general production documentation.
- Ensure that all documentation is completed accurately and in full compliance with ALCOA and Data Integrity (DI) principles.
- Ensure adherence to the batch release schedule by delivering completed eBR documentation to the Quality Operations (QO) department within the required timelines.
- Support production schedule adherence by ensuring the availability and proper management of consumables and manufacturing materials (consumption, returns, and

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