The Quality Assurance - Compliance Specialist II - Audit and Inspection will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.
- Work collaboratively with site management to instill a ‘Quality Culture' by coaching in the application of GMP Principles including the underlying rational of those principles.
- Mentor peers towards achieving organizational and individual goals.
- Compliance Delivery
- QA support to the organization during client audits and regulatory inspections to determine suitability, effectiveness, and compliance with applicable standards and regulations.
- Displays critical thinking expertise, with the ability to define and implement a strategic approach to audit- based on compliance and business knowledge.
- New Business Growth
- Support client due diligence and Quality audits as well as regulatory inspections.
- Work with Quality management to ensure quality systems support cGMP manufacturing of pre-clinical to commercial products.
- Ensure self-have no overdue training, or site actions. Support other QA teams and other functions in completion of site actions.
- Provide cGMP guidance to other functions such as Manufacturing, Facilities and QC, Warehouse and Validations.
- Support Site Readiness Preparation for Regulatory Inspections.
- Staying aware and up to date with agency regulations, guidance documents, and industry best practices, to ensure Fujifilm, Texas site is held to current standards
- Execute audit strategy and lead process audits
- Monitor quality in support of maintaining inspection readiness
- Provides support during regulatory inspections or customer audits as requested by the company, before, during and/or after the event.
- Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
- Ensure audit and inspection reports are responded on time.
- Works on complex problems in which analysis of situations or data requires in-depth evaluation of various factors from many sources. Is adept at interpreting GMP regulations in the resolution of problems and in the design of systems, processes or procedures.
- Ability to effectively plan, organize, and execute work that ensures deliverables are consistently met
- 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 work.
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.
- 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 associated with this position.
- 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.
- Must be willing to work flexible hours.
- Ability to work weekends and off-shift hours, as needed to support manufacturing activities.
- Must be willing to travel occasionally, as needed.
- Attendance is mandatory.
- Associate degree in a related science concentration with 5 years of experience in a regulated industry, including 2 years 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
- Master's degree in a related science concentration with 1 years of experience of cGMP supporting pharmaceutical or biotechnology products.
- Some exposure to good documentation practices, cGMP/GLP regulations.
- Certified Quality Auditor
- Degree in Biology, Chemistry or Engineering
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 979-431-3528.