Senior QA Analyst - All Shifts

Fujifilm; College Station (TX); On-site; USD 75,000 - 95,000; Full time

Job summary

Fujifilm is seeking a Senior Quality Assurance (QA) Analyst based in College Station, TX. This role involves reviewing technical documentation, drafting Quality policies, and performing audits to ensure compliance with industry standards.

The ideal candidate will hold a Master’s degree with experience in pharmaceutical or regulated industries, possess strong communication skills, and be capable of independently guiding the QA department.

Qualifications

• Strong background in Quality Assurance in regulated industries.
• Ability to provide compliance guidance to departments.
• Experience in drafting Quality policies and documentation.

Responsibilities

• Review and approve technical documentation with minimal oversight.
• Perform Quality audits and identify improvement opportunities.
• Support Regulatory, client, and internal audits as a QA liaison.

Skills

Excellent written and oral communication skills

Excellent organizational skills

Multitasking ability

Microsoft Excel proficiency

Knowledge of cGMP regulations

Analytical skills

Education

Master’s Degree and 3+ years of experience

Bachelor’s Degree and 5+ years of experience

Associate’s degree and 7+ years of experience

Certified Quality Auditor preferred

Degree in Biology or Chemistry preferred

Tools

Microsoft Word

Microsoft PowerPoint

Job description

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

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.

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]).