- Review and/or approve basic and technical documentation with minimal supervisory oversight to include, but not limited to:
- Master production records
- Equipment, software, and facility qualifications
- Standard Operating Procedures
- Batch Production Records (completed and approval)
- Lead Investigations into confirmed OOS
- Commissioning, qualification, and validation protocols and reports
- Deviation/CAPA Reports
- Technical data review and approval of documents
- QC data review and approval
- Drug Substance/Product Reports
- Trending QA data
- KPI reporting on a daily, weekly, and monthly basis
- Area/Room Release for production
- On-floor QA Support
- Draft/review/approve internal Quality 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
- Lead vendor, supplier, contract laboratory
- Identify process and Quality System improvement opportunities and suggest improvement ideas to Quality Management.
- Support Regulatory, client, and internal audits.
- Act as QA liaison to internal Departments and external Client Quality Groups and Vendor/Contract Laboratory Quality Groups providing daily guidance for the compliance to national and international standards and regulations.
- Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
- Work directly with Manufacturing when necessary
- All other duties as assigned by management.
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.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Vision correctable to 20/20.
- Attendance is mandatory.
- Master’s degree preferably in a science related field with 4 years’ experience in Quality Assurance supporting pharmaceutical, biopharmaceutical or biotechnology products of which a minimum of 3 years must have been in a cGMP environment; OR
- Bachelor’s degree preferably in a science related field with 6 years’ experience in Quality Assurance supporting pharmaceutical, biopharmaceutical or biotechnology products of which a minimum of 4 years must have been in a cGMP environment; OR
- Associates Degree, High School Diploma, or equivalent certificate with a minimum of 10 years’ experience in Quality Assurance of which a minimum of 6 years must have been in a cGMP environment.
- Software application knowledge of TrackWise, Master Control, Blue Mountain, ComplianceWire
- Certified Quality Auditor (CQA)
- Degree in Biology, Chemistry or related field
- Other training in cGMP compliance
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.