- Provides QA direction to the validation team during document review to ensure the organization is complying with local and global quality standards, regulatory requirements and partner commitments.
- Work collaboratively with other site functions to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.
New Business Growth
- Support client due diligence and Quality audits as well as regulatory inspections.
- Reviews and approves master plans, pre/post approval of qualification and validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Reviews and approves qualification and validation deviations and discrepancies, supports investigations and corrective actions.
- Participate in design reviews, and have experience in reading P&ID’s and various engineering drawings.
- Coordinate with Validation, Metrology, Facilities, Engineering, on a daily bases to ensure any GMP protocols, requirements etc are completed in a timely manner
- Utilize investigative techniques to determine root causes of discrepancies and proper corrective and preventative actions.
- Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
All other duties as assigned
Required Skills & Abilities:
- 5-10 years qualification/validation experience
- Experience with qualification/validation of process equipment, clean utilities, automation, sterile filling, aseptic processing, facilities, HVAC, and new construction final qualification requirements of TOP’s for GMP facilities.
- Single Use and Process Validation a plus
- 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.
- Master’s degree in a science-related field with 3 years of related experience; OR
- Bachelor’s degree in a science-related field with 5 years of related experience
- At least 5 years of cGMP experience.
- 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 979-431-3528.