- Review basic and technical documentation to include, but not limited to:
- Standard Operating Procedures
- Batch Production Records
- Commissioning, qualification and validation protocols and reports
- Deviation Reports
- Corrective Action/Preventive Action Plans
- Data Reports
- Drug Substance/Product Reports
- Review internal Quality policies, procedures and reports
- Assist in and perform inspection of final product containers and review and/or approval of executed process records and data
- Assist in and 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
- Identify process and Quality System improvements
- Act as a QA liaison to internal Departments and Vendor/Contract Laboratory Quality Groups
- Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
- All other duties as needed.
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
- 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 Office
- All candidates will have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products
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 sitting, some bending, stooping and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- 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.
- Bachelor’s degree in a related science concentration with 2 years of experience in Quality Assurance supporting pharmaceutical or biotechnology products; OR
- Master’s degree in a related science concentration with 1 years of experience in Quality Assurance supporting pharmaceutical or biotechnology products;
- Some exposure to good documentation practices, cGMP/GLP regulations.
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 e-mail FDBTHR@fujifilm.com or call 979-431-3528.