QA Analyst I, Analytical - Day Shift(On-Site in ...
FUJIFILM Diosynth Biotechnologies - college station, TX
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***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 andor 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 SupervisorManager, QAWork Location College Station, TX Primary Responsibilities:Assist with review of basic documentation to include, but not limited to: Standard Operating Procedures, Corrective ActionPreventive Action Plans, and Data ReportsAssist with review of internal quality policies, procedures, and reports. Assist with inspection of final product containers and review andor 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 questionnairesNotify 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; ORAssociate's degree in a related science concentration with 2+ years of experience in Quality Assurance supporting pharmaceutical or biotechnology products; ORHigh School Diploma or GED with 4+ years of experience in Quality Assurance supporting pharmaceutical or biotechnology products required. ASQ Certification preferred. Knowledge of GMPGLP 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.
Created: 2024-09-20