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. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FUJIFILM Diosynth Biotechnologies call Genki. 

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

Primary Responsibilities:

• Review and/or approve basic and technical documentation with minimal supervisory oversight to include, but not limited to:

o Standard Operating Procedures

o Batch Production Records (completed and approval)

o Commissioning, qualification and validation protocols and reports

o Deviation Reports

o Corrective Action/Preventive Action Plans

o Technical data review and approval

o QC data review and approval

o Drug Substance/Product Reports

o 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:

o Audit of lab notebooks

o Audit of equipment logbooks

o Review of vendor, supplier, contract laboratory audit questionnaires

o 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:

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.