Review basic and technical documentation to include, but not limited to:
Standard Operating Procedures
Analytical Methods
Disposition certificates
Batch Production Records
Corrective Action/Preventive Action Plans
QC Data review
Technical Data Review
Drug Substance/Product Reports
Review internal Quality policies, procedures and reports.
Assist in and perform Quality audit functions to include, but not limited to:
Audit of lab notebooks
Audit of equipment logbooks
Act as a QA liaison to internal Departments and Vendor/Contract Laboratory Quality Groups.
Notify Supervisor of potential quality or regulatory issues that may affect product quality or regulatory compliance.
All other duties as needed.
Qualifications:
Master's degree in a related science concentration with 1+ year of experience of cGMP supporting pharmaceutical or biotechnology products; OR
Bachelor's degree in a related science concentration with 2+ years of experience of cGMP supporting pharmaceutical or biotechnology products; OR
Associate's degree in a related science concentration with 4+ years of experience in a regulated industry, including 2+ years of experience of cGMP supporting pharmaceutical or biotechnology products; OR
High school diploma or GED and 6+ years of experience in a regulated industry, including 2+ years of experience of cGMP supporting pharmaceutical or biotechnology products.
ASQ Certification 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 adapt to frequent and rapid changes in the work environment and allocate, adjust and optimize time accordingly.
Ability to work independently and establish work priorities to meet targets and timelines
Proficient in Microsoft Excel, Word and PowerPoint.
All candidates will 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 sitting, 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 with this position.
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.
Lifting up to 25 pounds on occasion.
Ability to wear restrictive gowning for extended periods of time during periods of prolonged standing.
Attendance is mandatory.
Join us! FDB is advancing tomorrow's 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.
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please email FDBTHR@fujifilm.com or call 979-431-3500.