QA Analyst II

1 day 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.


  • college station, United States FUJIFILM Diosynth Biotechnologies Full time

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

  • QA Investigator II

    2 months ago


    College Station, United States BioPharma Consulting JAD Group Full time

    Job DescriptionJob DescriptionSummary: BioPharma Consulting JAD Group is seeking a highly motivated and detail-oriented individual to join our quality assurance team as a QA Investigator II. The QA Investigator II is responsible for supporting and leading deviation investigations to ensure accurate, thorough, and on time completion. The incumbent applies...

  • Financial Analyst II

    4 weeks ago


    College Station, United States Texas A&M University Full time

    The Financial Analyst II, within the Division of Finance, is responsible for maintaining current and accurate lease and IT subscription data in coordination with the campus community. Ensures expense transactions are properly reconciled against lease Financial Analyst, Financial, Accounting, Information Technology, Analyst, IT


  • 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...


  • College Station, Texas, United States FUJIFILM Corporation Full time

    Job SummaryThe Quality Assurance (QA) Compliance Analyst II, Supplier Quality will play a critical role in supporting the supplier quality program at FUJIFILM Corporation. This position will be responsible for ensuring all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility.Key ResponsibilitiesCompliance:...


  • College Station, Texas, United States Brown & Root Full time

    Job Title: Construction Superintendent IIAt Brown & Root, we are seeking a highly skilled Construction Superintendent II to join our team. As a key member of our construction team, you will be responsible for overseeing the execution of construction projects, ensuring compliance with company procedures and project management guidelines.Key...


  • College Station, Texas, United States Brown & Root Full time

    Job Title: Construction Superintendent IIWe are seeking a highly skilled Construction Superintendent II to join our team at Brown & Root. As a key member of our construction team, you will be responsible for overseeing the execution of construction projects, ensuring compliance with contract requirements and project management procedures.Key...


  • College Station, Texas, United States Fujifilm Diosynth Biotechnologies Full time

    Senior QA Analyst Job DescriptionFujifilm Diosynth Biotechnologies is seeking a highly skilled Senior QA Analyst to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our products.Key Responsibilities:Review and approve basic and technical documentation, including Standard...


  • College Station, Texas, United States Fujifilm Full time

    Job SummaryFujifilm is seeking a highly skilled Quality Assurance Specialist II, Validation to join our team. This role will be responsible for ensuring the quality and compliance of our pharmaceutical products.Key ResponsibilitiesReview and approve basic and technical documentation, including Standard Operating Procedures, Analytical Methods, and Batch...


  • College Station, Texas, United States Fujifilm Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist II, Validation to join our team at Fujifilm. This role will be responsible for ensuring the quality and compliance of our pharmaceutical products.Key ResponsibilitiesReview and approve basic and technical documentation, including Standard Operating Procedures, Analytical Methods, and...


  • College Station, Texas, United States Fujifilm Diosynth Biotechnologies Full time

    Senior Quality Assurance AnalystFujifilm Diosynth Biotechnologies is seeking a highly skilled Senior Quality Assurance Analyst to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our products.Key Responsibilities:Review and approve basic and technical documentation,...


  • College Station, Texas, United States Fujifilm Diosynth Biotechnologies Full time

    Quality Assurance Analyst IIIFujifilm Diosynth Biotechnologies is seeking a highly skilled Quality Assurance Analyst III to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our products.Key Responsibilities:Review and approve basic and technical documentation, including...


  • College Station, Texas, United States Fujifilm Full time

    Job SummaryWe are seeking a highly skilled QC Analyst II, Cell Biology to join our team at Fujifilm. The successful candidate will be responsible for participating in the technology transfer of established methods into our Quality Control Laboratory.Key ResponsibilitiesParticipate in training the QC Bioassay Staff in the established release methods.Perform...


  • College Station, United States Brown & Root Full time

    Job Description General Superintendent – Job Order ContractDUTIES AND RESPONSIBILITIES:• Manager multiple craft subcontractors engaged in field construction activities• Provide constructability advice• Manage the delivery order execution in accordance with contract requirements and projectmanagement procedures• Responsible for execution of work in...


  • College Station, Texas, United States Fujifilm Diosynth Biotechnologies Full time

    Quality Assurance Analyst IIIFujifilm Diosynth Biotechnologies is seeking a highly skilled Quality Assurance Analyst III to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our products.Key Responsibilities:Review and approve basic and technical documentation, including...


  • College Station, Texas, United States Fujifilm Full time

    Quality Assurance Analyst IIIAt Fujifilm, we are committed to advancing tomorrow's medicine and empowering our employees to chase the impossible. We are seeking a highly skilled Quality Assurance Analyst III to join our team in College Station, TX.Job SummaryThe Quality Assurance Analyst III will be responsible for reviewing and approving basic and technical...


  • College Station, Texas, United States FUJIFILM Corporation Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Analyst to join our team at FUJIFILM Corporation. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our products and processes.Key ResponsibilitiesReview and approve basic and technical documentation, including Standard...


  • College Station, Texas, United States FUJIFILM Corporation Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Analyst to join our team at FUJIFILM Corporation. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our products and processes.Key ResponsibilitiesReview and approve basic and technical documentation, including Standard...


  • College Station, Texas, United States Fujifilm Full time

    Quality Assurance Analyst IIIAt Fujifilm, we are committed to advancing tomorrow's medicine and empowering our employees to chase the impossible. We are seeking a highly skilled Quality Assurance Analyst III to join our team in College Station, TX.Key Responsibilities:Review and approve basic and technical documentation, including Standard Operating...


  • College Station, Texas, United States Fujifilm Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist II, Supplier Quality to join our team at Fujifilm. This role will be responsible for supporting the supplier quality program and ensuring all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility.Key ResponsibilitiesCompliance: Serve...