Quality Control Scientist for Raw Materials
1 week ago
Position Overview:
Join Fujifilm's innovative team at our advanced Life Science Manufacturing Facility, where we are dedicated to making a significant impact in the biopharmaceutical industry.
As a Quality Control (QC) Raw Materials Scientist, you will play a crucial role in the Technology Transfer of raw material methodologies into our Quality Control Laboratory, operating with a degree of autonomy.
Your responsibilities will include:
- Onboarding new and generic raw materials for various customer programs.
- Conducting assessments and establishing QC raw material requirements.
- Executing action items related to change controls based on vendor documentation.
- Collaborating with cross-functional teams to identify materials.
- Planning and monitoring QC readiness for both clinical and commercial manufacturing.
- Providing technical expertise to evaluate testing strategies, verification, and validation needs.
- Performing QC reviews of Specification Justification Reports (SJR).
- Offering technical support for troubleshooting investigations concerning new materials.
- Authoring specifications in accordance with SJR and managing LIMS builds for new materials.
Key Responsibilities:
In this role, you will also be responsible for:
- Coordinating and overseeing raw material release processes.
- Preparing monthly metrics related to raw material releases.
- Conducting sampling, release, and chemical analysis of materials as necessary.
- Representing the QC Raw Materials team in internal and external technical transfer meetings.
- Implementing new raw materials, including authoring specifications and assessing changes.
- Managing Trackwise deviations, CAPAs, lab exceptions, and invalid assays.
- Ensuring compliance with cGMP standards and participating in audits and inspections.
Qualifications:
To be successful in this position, you should possess:
- A B.A./B.S. degree in Chemistry, Biology, Microbiology, Biochemistry, or a related scientific field.
- 6+ years of relevant experience, including at least 3 years in a GMP environment.
- In-depth knowledge of raw material methodologies as they relate to cGMP.
- Experience in troubleshooting assays and problem-solving.
Physical and Environmental Requirements:
Candidates must be able to:
- Stand or sit for extended periods.
- Perform repetitive motions involving hands and fingers.
- Lift objects weighing up to 10 pounds.
- Work in varying temperature conditions.
Fujifilm is committed to fostering an inclusive workplace. We encourage all qualified applicants to consider joining our team, where you can contribute to meaningful advancements in healthcare.
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