QA Analyst I, Analytical

2 months ago

college station, United States FUJIFILM Diosynth Biotechnologies Full time

***This is an on-site position in College Station, TX.


The Quality Assurance (QA) Analyst I, under direct supervision, will be responsible for assisting with the review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting with product related activities; Assisting with Quality audit functions; Identifying process and Quality System improvements.


Reports to Supervisor/Manager, QA

Work Location College Station, TX


Primary Responsibilities:

  • Assist with review of basic documentation to include, but not limited to: Standard Operating Procedures, Corrective Action/Preventive Action Plans, and Data Reports
  • Assist with review of internal quality policies, procedures, and reports.
  • Assist with inspection of final product containers and review and/or approval of executed process records and data.
  • Assist in Quality audits to include, but not limited to: audit of lab notebooks, audit of equipment logbooks, and review of vendor, supplier, contract laboratory audit questionnaires
  • Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
  • All other duties as needed.


Qualifications:

  • Bachelor’s degree in a related science concentration with some experience in Quality Assurance supporting pharmaceutical or biotechnology products; OR
  • Associate’s degree in a related science concentration with 2+ years of experience in Quality Assurance supporting pharmaceutical or biotechnology products; OR
  • High School Diploma or GED with 4+ years of experience in Quality Assurance supporting pharmaceutical or biotechnology products required.
  • ASQ Certification preferred.
  • Knowledge of GMP/GLP regulations 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 Office.
  • All candidates will have a working knowledge of cGMP regulations to produce drug, biologics, or vaccine products.
  • Role model for company core values of trust, delighting our customers, Gemba, and Genki.

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