GMP Documentation Coordinator
2 days ago
About the Company
Fujifilm Diosynth Biotechnologies is a leading Contract Development and Manufacturing Organization (CDMO) that enables the success of innovative biotech and biopharma companies. We have a strong commitment to diversity, inclusion, and sustainability, and we strive to foster a collaborative and rewarding work environment.
About the Role
We are seeking a highly motivated and detail-oriented individual to join our Drug Substance Manufacturing Support team as a GMP Documentation Coordinator. As a key member of our team, you will play a critical role in supporting manufacturing operations with project management and compliance of procedures and documentation.
Key Responsibilities:
- Coordinate different types of documents for DSM.
- Issue documents and labels for DSM.
- Review BPRs and logbooks.
- Create and maintain records and procedures by collecting information from stakeholders.
- Perform timely closure of action items to ensure reliable execution of production.
- Continuous improvement of department processes and support of stakeholder improvement projects.
Qualifications and Skills
We are looking for a responsible, conscientious, and proactive individual who is ready for professional development. You should be able to navigate on your own, in a team, and among many stakeholders.
Requirements:
- Experience with cGMP and pharmaceutical manufacturing, preferably 2-5 years in the industry.
- Educational background in engineering, science, pharmacy, or similar field.
- Knowledge about Cell Culture and Purification unit operations.
- Fluency in English language.
About Us
We offer a competitive compensation package, opportunities for professional and personal development, and a chance to be part of a global workplace where passion, drive, and commitment are met with opportunities for growth. We are committed to fostering a diverse and inclusive work environment and promoting equal opportunities for all employees.
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