How will you make an impact?
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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 75,000 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.
Responsibilities:
- Administratively support Manufacturing Batch Record procedures for document issuance, control and review
- Creating and / or revising procedures and work instructions and process them in quality document management system
- Maintain files and records supporting site Document Control quality management process.
- Revise and route document change requests and document approval activities in accordance with GMP and quality standards.
- Maintains and coordinates documentation as required for manufacturing such as Batch Records, Logbooks, Forms, and other documentation activities as required. Prepare all documentation as assigned.
- Supports the creation of SOPs, manufacturing batch records and other GMP required documentation by formatting and word processing, as needed.
- Receives and verifies manufacturing batch records. Shall review work orders/batch records and be able to verify all components and correct lot numbers to be used are correct.
- Supports the review of documents for completeness and accuracy. Review final batch record/work orders information for completeness.
- Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements. Brings regulatory compliance questions/issues to the attention of management.
- Promotes a safe work environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices.
- Provide recommendations to support systems that continuously improve product/process quality and product availability, reduce cost, and increase production capability.
- Performing Shop Floor transactions in the Enterprise Resource Planning (ERP) System.
- Performing financial variance reviews prior to full completion of Work Orders.
- Plan, develop, organize, write and edit operational procedures and manuals
- Create user documentation for a variety of material, including job aides and work instructions
- Work with internal teams to obtain in-depth understanding of all equipment and documentation requirements.
- Excellent interpersonal skills are required. Teamwork is essential as coordination between Documentation Control personnel is mandatory.
- Overtime/Off Shift On-site support may be required
- All other duties as assigned by Supervisor