Senior QA Analyst, Analytical

College Station, TX - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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 Biotechnologies Texas has never been more importantand we are looking for passionate mission-driven people like you who want to make a real difference in peoples lives.

From developing the next vaccine to advancing cell and gene therapies we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.

If youre ready to help transform the future of medicine join FUJIFILM Biotechnologies. We offer a flexible work environment and were proud to cultivate a culture that will fuel your passion energy and drivewhat we call Genki.

Our state-of-the-art biomanufacturing facility is located in in College Station Texas which combines a small-town feel with vibrant culture top-notch schools and close proximity to big city life. Nestled between major hubs its a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: 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:

Masters Degree and 3 years of Pharmaceutical or other regulated Industry experience.
Bachelors Degree and 5 years of Pharmaceutical or other regulated Industry experience.
Associates 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 tomorrows 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.

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committedto 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 ( or ).

Required Experience:

Senior IC

Position OverviewThe 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 fun...