QA Supervisor, Operations

College Station, TX - USA

Monthly Salary: Not Disclosed

Posted on: 7 hours ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

The Quality Assurance (QA) Supervisor will be responsible for the overall performance of the QA group. The supervisor will handle all associated responsibilities in compliance with FUJIFILM quality policies and site SOPs to ensure regulatory compliance.

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

Reports to Senior Manager Quality Assurance

Work Location College Station TX

Essential Functions:

Supervise and provide direction to direct reports.
Serve as TrackWise Administrator.
Monitor and support site and global quality policies and procedures to ensure GMP compliance.
Work with QA management to design and implement quality assurance training programs for staff development.
Provide cGMP guidance to operations QC and QA.
Lead client audits and regulatory inspections.
Utilize investigative techniques to determine root causes of deviations and proper corrective and preventative actions.
Develop motivate and lead direct reports towards achieving organizational and individual goals.
Conduct periodic staff meetings.
Review and/or approve basic and technical documentation 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
Manage Internal 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
Identify process and Quality System improvement opportunities.
Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Assist with compliance related functions.
Work as a team member; be cooperative with all departments and staff to meet company objectives.
All other duties as assigned.

Required Skills & Abilities:

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.
Develop staff to maximize contributions to the team and the company.
Ability to multitask and easily prioritize 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 and Gemba.

Working Conditions & 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.
Ability to sit for long periods to work on a computer.
Potential for exposure to chemicals gases fumes odors dusts and other hazardous materials.
Ability to wear personal protective equipment including but not limited to safety glasses lab coat gloves specialized clothing including laboratory scrubs (pants and shirt) cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
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.
Must be willing to work flexible hours.
Ability to work weekends and off-shift hours as needed to support manufacturing activities.
Must be willing to travel occasionally as needed.
Attendance is mandatory.

Qualifications:

Masters degree in a science-related field with 3 years of related experience; OR
Bachelors degree in a science-related field with 5 years of related experience.
2 years of prior supervisory or lead experience.
2 years of cGMP experience.

Preferred Qualifications:

Certified Quality Auditor
Degree in Biology Chemistry

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:

Manager

Position OverviewThe Quality Assurance (QA) Supervisor will be responsible for the overall performance of the QA group. The supervisor will handle all associated responsibilities in compliance with FUJIFILM quality policies and site SOPs to ensure regulatory compliance. Company OverviewThe work we d...