Senior QA Analyst

2 days ago

Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full time
Position Overview

The Senior Quality Assurance (QA) Analyst, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally. They will also provide daily guidance, work prioritization and support to other departments, such as manufacturing or QC, in absence of or in conjunction with their manager.

Reports to: Director/Senior Manager/Supervisor, Quality Assurance

Work Location: College Station, TX

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives.

Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe.

Job Description

Primary Responsibilities:

  • Review and/or approve basic and technical documentation with minimal supervisory oversight to include, but not limited to:
    • Standard Operating Procedures
    • Batch Production Records (completed and approval)
    • Commissioning, qualification and validation protocols and reports
    • Deviation Reports
    • Corrective Action/Preventive Action Plans
    • Technical data review and approval
    • QC data review and approval
    • Drug Substance/Product Reports
    • Trending QA data
  • Draft and review internal Quality policies, procedures and reports.
  • Perform inspection of final product containers and review and/or approval of executed process records and data.
  • Perform Quality audit functions to include, but not limited to:
    • Audit of lab notebooks
    • Audit of equipment logbooks
    • Review of vendor, supplier, contract laboratory audit questionnaires
    • Lead vendor, supplier, contract laboratory and client audits
  • Identify process and Quality System improvement opportunities.
  • Provide daily guidance for the compliance of the QA department to national and international standards and regulations.
  • Support Regulatory, client, and internal audits.
  • Act as QA liaison to internal Departments and external Client Quality Groups and Vendor/Contract Laboratory Quality Groups.
  • Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
  • Assist with technical oversight/training for the QA team.
  • Assist with compliance related functions.
  • Ensure priority task coverage.
  • Escalate any issues as identified to Quality Management and/or departmental Management as needed.
  • All other duties as assigned.

Qualifications:

  • Master's Degree and 3+ years of Pharmaceutical or other regulated Industry experience.
  • Bachelor's Degree and 5+ years of Pharmaceutical or other regulated Industry experience.
  • Associate's degree and 7+ years of Pharmaceutical or other regulated Industry experience.
  • Certified Quality Auditor 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 multitask and easily prioritize your work.
  • Ability to work independently with little supervision.
  • Proficient in Microsoft Excel, Word and PowerPoint.
  • All candidates must 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.

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 standing, some bending, stooping, and stretching.
  • Lifting up to 25 pounds on occasion.
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
  • Attendance is mandatory.

Join us FDB is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBTHR@fujifilm.com or (979) 431-3500).

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