What are the responsibilities and job description for the Thermo Fisher Scientific is hiring: Technical Writer II in Bend position at Thermo Fisher Scientific?
Work Schedule
Standard (Mon-Fri)
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
Summary :
Support Manufacturing Department by leading technical transfer of products from Formulation and Process Development. Drafts and reviews Master Batch Records and contributes to manufacturing related deviation investigations.
Essential Functions :
- Works with cross function project team to define product parameters and transfer processes from Formulation and Process Development to the cGMP plant.
- Authors Master Batch Records (MBRs) for all processes supported by the site, which are spray drying, secondary drying, oral solid dosage and packaging.
- Manages document approval work flows to enable a successful production schedule.
- Leads and authors Manufacturing related deviations and investigations using root cause analysis tools to determine CAPA.
- Reviews draft documents from other technical writers for cGMP compliance and technical efficiency.
- Maintains and continuously improves library of MBR templates for every unit operation.
- Reviews completed batch records and catalogs observations for future revisions.
- Learns new processes and materials that can improve site expertise and capabilities.
- Drafts & revises Standard Operating Procedures (SOPs) for the Manufacturing department.
- Trains the manufacturing team on SOPs and Batch Records.
Education :
Experience :
Equivalency :
Proficiencies :
Physical Requirements :
Disclaimer :
This job description aims to outline the overall content and requirements for performing this job. The description should not be seen as a comprehensive statement of work, responsibilities, or requirements. Additional duties may be assigned by managers and supervisors.
This document does not establish an employment contract. Skills / experiences are briefly stated in job descriptions to align with legal requirements.
