Pharmaceutical Documentation Specialist with Aseptic Expertise
5 giorni fa
Thermo Fisher Scientific Inc., the world leader in serving science, is a dynamic organization dedicated to enabling its customers to make the world healthier, cleaner, and safer. We offer unparalleled opportunities for growth and development.
About the RoleThis exciting opportunity is part of our pharmaceutical contract manufacturing and development processes, focusing on the production of aseptic injectable drugs and biologics. As a key member of our team, you will be responsible for ensuring the flawless execution of these processes.
Responsibilities- Collaborate with the team to review, draft, and issue specifications that guarantee production quality.
- Manage internal change control processes to ensure seamless operations.
- Prioritize and complete assigned training to maintain expertise and adherence to current procedures.
- Produce relevant documentation based on team needs and priorities.
- Achieve data integrity by adhering to strict rules and ensuring all activities and data are compliant.
- Bachelor's degree in scientific fields (CTF, Biology, Biotechnology, etc.).
- Minimum of 5 years of experience in pharmaceutical or biotech industries with a focus on documentation and GMP knowledge.
- Proficiency in Microsoft Office, PC usage, and document management systems.
- Good command of the English language.
- Ability to outline processes and documents.
- Knowledge of TrackWise and Documentum systems is preferred.
The estimated annual salary for this role is $80,000 - $110,000, commensurate with experience and qualifications.
We value diversity and are committed to providing equal employment opportunities to all individuals regardless of race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age, or disability status.
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