Job summary
Job post source
This job is directly from FUJIFILM Biotechnologies
Job overview
The QA Specialist, DSM role at FUJIFILM Biotechnologies involves quality oversight of Drug Substance Manufacturing processes to ensure compliance and validated operations within a cGMP regulated facility.
Responsibilities and impact
The QA Specialist provides QA oversight of DSM operations including batch record reviews, real-time event triage, work order oversight, and supports validation and quality documentation development to meet department KPIs and operational readiness.
Experience and skills
Candidates should have a BS/BA in Life Sciences or Engineering with 2+ years relevant experience or a Masters with no experience, 1-3 years in GMP environments, and knowledge of validation and quality oversight in FDA regulated facilities; preferred experience includes GMP Quality Assurance and familiarity with ASTM E2500 and validation software like Trackwise and MasterControl.
Work environment and culture
The company emphasizes compliance with cGMP standards and operational efficiency, with a regulated and safety-conscious work environment requiring physical ability to perform tasks involving standing, sitting, and repetitive motions.
Company information
FUJIFILM Biotechnologies is a company focused on biotechnological manufacturing under cGMP regulations, involved in drug substance manufacturing and quality assurance.
Application process
Applicants are advised that FUJIFILM does not accept unsolicited resumes from agencies without a valid agreement, indicating a direct application process with strict agency policies.
Unique job features
The role involves real-time quality oversight and use of advanced quality management tools in a regulated biomanufacturing environment, distinguishing it from similar roles by its focus on operational readiness and cross-site efficiency initiatives.
Company overview
FUJIFILM Biotechnologies is a division of FUJIFILM Corporation focused on providing advanced solutions in biopharmaceutical manufacturing, cell and gene therapy, and life sciences research. The company generates revenue by offering contract development and manufacturing services (CDMO), proprietary technologies, and specialized products to pharmaceutical and biotech clients worldwide. FUJIFILM has expanded its biotechnology presence through strategic acquisitions such as Diosynth Biotechnologies and investments in state-of-the-art manufacturing facilities. Its history is rooted in FUJIFILM’s transformation from a traditional photography business to a global leader in healthcare and biotechnology innovation. Candidates should be aware of the company’s commitment to quality, innovation, and supporting the development of cutting-edge therapies.
How to land this job
Position your resume to highlight your experience in GMP Quality Assurance, validation, and cGMP manufacturing operations within FDA-regulated environments, as these are central to the QA Specialist role at FUJIFILM Biotechnologies.
Emphasize familiarity with QA oversight tasks such as batch record reviews, deviation management, and real-time work order oversight, along with knowledge of relevant software like Trackwise, MasterControl, or Kneat, as mentioned in the job description.
Apply through multiple channels including FUJIFILM Biotechnologies' official corporate careers page and LinkedIn to maximize your application visibility for the QA Specialist openings.
Connect with current employees in the DSM or Quality Assurance divisions at FUJIFILM Biotechnologies on LinkedIn; start conversations by referencing recent company initiatives in quality improvements or asking about their experience with validation software to break the ice.
Optimize your resume for ATS by incorporating keywords from the job description such as 'QA oversight,' 'cGMP,' 'validation,' 'FDA regulated,' 'batch record review,' and specific software names to ensure your resume passes automated screenings.
Use Jennie Johnson's Power Apply feature to automate tailored applications across multiple platforms, identify key LinkedIn contacts for networking, and ensure your resume is ATS-optimized, allowing you to focus your time on meaningful engagement during your job search.
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