Scientific Documentation Specialist
1 week ago
We are seeking a highly skilled Scientific Technical Writer to join our team at Thermo Fisher Scientific.
This is a full-time position that offers a competitive salary of $65,000 - $85,000 per year, depending on experience.
About the Role:
The ideal candidate will have a strong background in scientific writing, with experience in creating and revising master batch records (MBRs) for manufacturing and packaging.
They will work closely with the Commercial/Pharmaceutics & Process Technology departments, Technical Project Leaders, and Project Managers to generate and approve MBRs.
The successful candidate will also be responsible for updating and maintaining master records and directories, following production schedule requirements, and preparing planned deviations to facilitate manufacturing and packaging activities.
Key Responsibilities:
- Create and revise master batch records (MBRs) for manufacturing and packaging
- Work closely with Commercial/Pharmaceutics & Process Technology departments, Technical Project Leaders, and Project Managers to generate and approve MBRs
- Update and maintain master records and directories
- Follow production schedule requirements
- Prepare planned deviations to facilitate manufacturing and packaging activities
- Develop bill of materials for new products
- Verify accuracy of bill of materials and item master information
- Create and ensure current approved Shipper Labels and Shelf Pack Labels
- Generate and update Shipper Fill Diagram and Pallet Pattern
- Coordinate official sign-off circulation and implementation of Master Manufacturing and Packaging Records
- Control, compile, and maintain Product Technical Files for all products
- Control access to MBRs and provide current Master Records to Planning
- Generate and revise Change Control to master records and generation of new Master Records
- Issue batch records ensuring all planned deviations noted as required
Requirements:
Education:
College Diploma in Science/Technical related field (Food or Drug). B.Sc. is an asset.
Experience:
Minimum of 3 years related experience with report writing and batch record preparation preferred.
Knowledge, Skills and Abilities:
Strong written and oral communication skills. Good technical skills and capability to understand different manufacturing and packaging processes. Well organized and detail-oriented. Knowledge of Good Manufacturing Practices and ability to follow Standard Operating Procedures (SOPs).
Physical Requirements:
Light physical effort and fatigue. Walks, sits, or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration.
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