The Quality Assurance (QA) - Compliance Specialist I for Audit & Inspection will be responsible for supporting all associated audit responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance, including supporting client audits, regulatory inspections, and conducting internal and supplier audits.
- 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.
- Compliance Delivery
- Support to the organization in conducting internal audits and hosting audits/inspections.
- New Business Growth
- Work with Quality management to ensure quality systems support cGMP manufacturing of pre-clinical to commercial products.
- Support the external and internal Audit Programs to be in an acceptable state of compliance.
- Responsible for audit preparations, conducting internal audits, and assisting client audits with site documentation gathering.
- Support Global Supplier Assurance - work with the global team to participate and represent Texas Site in supporting joint audits.
- Ensure self-have no overdue training, or site actions. Support other QA teams and other functions in completion of site actions.
- 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.
- High School or equivalent: 6 years or more of Pharmaceutical or other Regulated Industry experience.
- Associates Degree: 4 years or more of Pharmaceutical or other Regulated Industry experience.
- Bachelor's Degree: 2 years or more of Pharmaceutical or other Regulated Industry experience.
- Master's Degree: 1 year or more of Pharmaceutical or other Regulated Industry experience.
- Knowledge of GMP/GLP regulations
- 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.