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Quality Assurance - Analyst II

Company: FUJIFILM Diosynth Biotechnologies
Location: College Station
Posted on: June 13, 2021

Job Description:

Summary: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. External US Essential Functions:Review basic and technical documentation to include, but not limited to:Standard Operating ProceduresBatch Production RecordsCommissioning, qualification and validation protocols and reportsDeviation ReportsCorrective Action/Preventive Action PlansData ReportsDrug Substance/Product ReportsReview internal Quality policies, procedures and reportsAssist in and perform inspection of final product containers and review and/or approval of executed process records and dataAssist in and perform Quality audit functions to include, but not limited to:Audit of lab notebooksAudit of equipment logbooksReview of vendor, supplier, contract laboratory audit questionnairesIdentify process and Quality System improvementsAct as a QA liaison to internal Departments and Vendor/Contract Laboratory Quality GroupsNotify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory complianceAll other duties as needed.Required Skills & Abilities:Excellent written and oral communication skillsExcellent organizational, analytical, data review and report writing skillsAbility to set personal performance goals and provide input to departmental objectivesAbility to adapt to frequent and rapid changes in the work environment and allocate, adjust and optimize time accordinglyAbility to work independently and establish work priorities to meet targets and timelinesProficient in Microsoft OfficeAll candidates will have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine productsWorking Conditions & Physical Requirements:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:Experience prolonged sitting, some bending, stooping and stretching.Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.Lifting up to 25 pounds on occasion. Ability to wear restrictive gowning for extended periods of time during periods of prolonged standing.Attendance is mandatory. Qualifications:Bachelor's degree in a related science concentration with 2 years of experience in Quality Assurance supporting pharmaceutical or biotechnology products; ORMaster's degree in a related science concentration with 1 years of experience in Quality Assurance supporting pharmaceutical or biotechnology products;Some exposure to good documentation practices, cGMP/GLP regulations. Preferred Qualifications: ASQ Certification We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please e-mail or call .

Keywords: FUJIFILM Diosynth Biotechnologies, College Station , Quality Assurance - Analyst II, Other , College Station, Texas

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