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QA Analyst II

3 months ago

college station, United States FUJIFILM Diosynth Biotechnologies Full time

The Quality Assurance (QA) Analyst II, under general direction, will be responsible for review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting in and performing product related activities; Assisting in and performing Quality audit functions; Identifying process and Quality System improvements; Acting as a QA liaison internally.


Reports to Supervisor/Manager, QA

Work Location College Station, TX


Primary Responsibilities:

  • Review basic and technical documentation to include, but not limited to: Standard Operating Procedures, Analytical Methods, Disposition certificates, Batch Production Records, Corrective Action/Preventive Action Plans, QC Data review , Technical Data Review, Drug Substance/Product Reports.
  • Review internal Quality policies, procedures and reports.
  • Assist in and perform Quality audit functions to include, but not limited to: Audit of lab notebooks, and audit of equipment logbooks
  • Act as a QA liaison to internal Departments and Vendor/Contract Laboratory Quality Groups.
  • Notify Supervisor of potential quality or regulatory issues that may affect product quality or regulatory compliance.
  • All other duties as needed.


Qualifications:

  • Master’s degree in a related science concentration with 1+ year of experience of cGMP supporting pharmaceutical or biotechnology products; OR
  • Bachelor’s degree in a related science concentration with 2+ years of experience of cGMP supporting pharmaceutical or biotechnology products; OR
  • Associate’s degree in a related science concentration with 4+ years of experience in a regulated industry, including 2+ years of experience of cGMP supporting pharmaceutical or biotechnology products; OR
  • ASQ Certification preferred.
  • Degree in Biology or Chemistry preferred.
  • Excellent written and oral communication skills.
  • Excellent organizational, analytical, data review and report writing skills.
  • Ability to set personal performance goals and provide input to departmental objectives.
  • Ability to adapt to frequent and rapid changes in the work environment and allocate, adjust and optimize time accordingly.
  • Ability to work independently and establish work priorities to meet targets and timelines.
  • Proficient in Microsoft Excel, Word and PowerPoint.
  • All candidates will have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
  • Role model for company core values of trust, delighting our customers, Gemba, and Genki.