What are the responsibilities and job description for the Specialist, QC Instrumentation position at FUJIFILM Biotechnologies?
The QC Specialist, Instrumentation works under the direction of senior team members to support routine operations, continuous improvement, and life-cycle management of the QC analytical instrumentation program. This role helps ensure compliance with Data Integrity standards, following regulatory guidelines and company procedures. The Specialist assists with routine maintenance, conducts periodic reviews of QC analytical instruments, and helps identify and address deviations or issues. The position also involves providing support for on-call and weekend coverage when needed.
What You’ll Do
- Supports the qualification, routine operation, maintenance, and decommissioning of QC analytical instruments.
- Ensures QC equipment and instruments adhere to regulatory guidelines and site policies.
- Assists in drafting and reviewing SOPs, technical reports, user requirements, and maintenance documentation.
- Participates in data integrity initiatives related to analytical instruments.
- Helps recommend appropriate user roles and privileges for data integrity and assists in writing operation instructions and preventative maintenance plans.
- Coordinates with vendors for maintenance activities on QC instruments.
- Completes routine periodic reviews of QC instruments and their control software.
- Identifies, reports, and follows up on excursions and deviations and assists in corrective and preventative actions (CAPAs).
- Provides support and guidance to stakeholders, including end users, on QC analytical instrumentation.
- Works cross-functionally with all end users as needed.
Knowledge, Skills, and Abilities
- Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, and Power Point).
- Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
- Excellent verbal and written communication skills and attention to detail.
- Thorough understanding of the pharmaceutical/biotech testing.
- Proven ability to understand and implement data integrity standard and regulations.
- Proven ability to conduct investigations, writing deviations and CAPA’s.
- Superior technical writing and problem-solving skills required.
- The ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success.
Minimum Qualifications
- Bachelor’s in relevant scientific discipline, preferably Chemistry, Biochemistry, Microbiology, Biology or Life Sciences.
- 0-3 years laboratory experience.
- Prior hands-on experience with analytical instrumentation associated with the following technologies: UPLC/HPLC, capillary electrophoresis/imaged capillary isoelectric focusing, gel electrophoresis/Western blot, plate readers, qPCR, spectrophotometry, and mass spectrometry.
Preferred Qualifications
- GMP laboratory experience.
- Experience with Kneat software.
- Experience qualifying analytical instruments.