Materials Analyst

1 week ago


Holly Springs, United States FUJIFILM Diosynth Biotechnologies Full time

The QC Raw Materials Sr. Analyst 1 is accountable for GMP compliant laboratory operations according to USP/EP/JP regulations. The role will be responsible for participating in the Technology Transfer of established methods into the FDBN Quality Control Laboratory. Following Tech-Transfer Activities, the position will be responsible for performing raw material testing and disposition using the established analytical methods.


  • Under supervision, support raw material life cycle management (new material assessment, specification establishment, maintenance of specifications etc.)
  • Supports 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


Minimum Requirements

  • 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 Requirements

  • 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.

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