QA Analyst III - All Shifts

FUJIFILM Holdings America Corporation; College Station (TX); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Analyst III to ensure compliance with quality standards and regulations. In this pivotal role, you will review and approve critical documentation, conduct audits, and identify opportunities for process improvement. You will be part of a mission-driven team dedicated to advancing medicine and making a meaningful impact on people's lives. This is an exciting opportunity for those who thrive in a dynamic environment and are passionate about quality assurance in the biopharmaceutical sector. Join us in shaping the future of healthcare!

Qualifications

• 8+ years in Pharmaceutical or regulated industry required.
• Knowledge of cGMP regulations essential for drug production.

Responsibilities

• Review and approve technical documentation with minimal oversight.
• Perform Quality audits and support regulatory compliance.

Skills

Excellent written communication skills

Excellent oral communication skills

Organizational skills

Analytical skills

Ability to multitask

Ability to work independently

Education

High school diploma or equivalent

Associates Degree

Bachelor’s Degree

Master’s Degree

Tools

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Job description

Position Overview

The Quality Assurance (QA) Analyst III, 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.

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

Work Location: College Station, TX (On-site at NCTM building)

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.
• All other duties as assigned.

Qualifications:

• High school or equivalent and 8+ years’ experience in Pharmaceutical or other regulated Industry.
• Associates Degree and 5+ years’ experience in Pharmaceutical or other regulated Industry.
• Bachelor’s degree and 3+ years’ experience in Pharmaceutical or other regulated Industry.
• Master’s Degree and 1+ years’ experience in Pharmaceutical or other regulated Industry.
• 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:

• 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.

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 ([e-mail] or [phone]).