QA Supervisor - 2pm-11pm

Position Overview

The Quality Assurance (QA) Operations 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.

Reports to: Senior Manager, 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:

• 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, including 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, including 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 audits
• 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.

Qualifications:

• Master’s degree in a science-related field with 3+ years of related experience; OR
• Bachelor’s degree in a science-related field with 5+ years of related experience.
• 2+ years of supervisory or lead experience.
• 2+ years of cGMP 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.
• 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, Gemba, and Genki.

Physical Requirements:

• 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, cleanroom 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.
• 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.

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.