Quality Assurance Compliance - Specialist III – Audit and Inspection
Summary: The Quality Assurance (QA) Specialist III for Audit & Inspection will be responsible for supporting and client audits, regulatory inspections, conducting internal and supplier assurance 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.
- Support to the organization in conducting internal and supplier audits and hosting audits/inspections.
New Business Growth
- Work with Quality management to implement quality systems that will enable 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, assisting client audits with site documentation gathering, leading “war room” when required.
- Support Global Supplier Assurance - work with the global team to participate and represent Texas Site in supporting joint audits.
All other duties as assigned.
Required Skills & Abilities:
- Travel will be required for conducting supplier audits
- 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.
- Develop staff to maximize contributions to the team and the company.
- Ability to multitask and easily prioritize 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.
- 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: 8 years or more experience in Pharmaceutical or other regulated Industry.
- Associates Degree: 5 years or more experience in Pharmaceutical or other regulated Industry.
- Bachelor Degree: 3 years or more experience in Pharmaceutical or other regulated Industry.
- Master's Degree: 1 year or more experience in Pharmaceutical or other regulated Industry.
- At least 4 years of cGMP experience.
- 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 e-mail FDBTHR@fujifilm.com or call 979-431-3500.