- Review and/or approve basic and technical documentation with minimal supervisory oversight 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
- 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:
- Audit of lab notebooks
- Audit of equipment logbooks
- Review of vendor, supplier, contract laboratory audit questionnaires
- 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.
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 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.
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.
- 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.
- Bachelor’s degree in related science concentration with 6 years’ experience in Quality Assurance supporting pharmaceutical, biopharmaceutical or biotechnology products; OR
- Master’s degree in related science concentration with 4 years’ experience in Quality Assurance supporting pharmaceutical, biopharmaceutical or biotechnology products.
- At least 2 years of experience working in a cGMP environment with exposure to good documentation practices.
- Certified Quality Auditor
- Degree in Biology or Chemistry
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.