108 applicants
FUJIFILM Diosynth Biotechnologies ยท 2 days ago
QC Raw Materials Sr. Analyst
Holly Springs, NC
Full-time
Onsite
Senior Level
3+ years exp
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Responsibilities
Under supervision, support raw material life cycle management (new material assessment, specification establishment, maintenance of specifications etc.)
Support QC Raw Materials team on internal tech transfer meetings related to new products.
Under supervision and support, authors and reviews procedures, protocols, reports, and specifications related to the raw material area.
Performs testing and disposition of incoming raw materials and components according to specifications and procedures.
Assesses and executes actions related to change controls and vendor change notifications from partners or driven by internal or compendial needs.
Responsible for initiation and execution of Trackwise deviations, CAPA's, lab exceptions, and invalid assays
Authors and implements corrective and preventative actions from approved deviations, CAPA's, lab exceptions, and invalid assays in Trackwise.
Performs routine investigations in support of out of specification testing results.
Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results.
Enforces established policies and procedures and escalates to management areas where enhancements will improve daily work.
Assists Manager, QC in the implementation of new technologies.
Adheres to pre-defined turnaround times of raw material testing.
Reviews new and updated specifications
Assesses lab exceptions and performs routine investigations.
Utilizes MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated
Performs other duties, as assigned
Qualification
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Required
B.A./B.S. degree in Chemistry, Biology, Microbiology, Biochemistry, or other relevant scientific discipline and 3 years relevant experience
Previous experience in a GMP environment required
Computer proficiency required
Preferred
Masters degree in Biology, Chemistry Biochemistry, Microbiology or other relevant scientific discipline with 1+ years experience
Familiar with Raw Material methodology as it pertains to cGMP
Experience in authoring and reviewing CAPAs, procedures, protocols, reports, and specifications related to the raw material area
Company
FUJIFILM Diosynth Biotechnologies
Fujifilm Diosynth Biotechn, contract development & manufacturing provider for preclinical, clinical and commercial biologics manufacturing.
1,001-5,000 employees
H1B Sponsorship
FUJIFILM Diosynth Biotechnologies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2022 (1)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Morten Munk
Director - Global Alliance Management
S
Sharyn Farnsworth
Associate Principal Scientist
Recent News
Wake County Government (.gov)
2024-05-24
Company data provided by crunchbase
