Summary: The Quality Assurance (QA) Analyst I, Supplier Quality will be responsible for supporting the supplier quality program. The Specialist will assist with ensuring all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility.
External US
Essential Functions:
Compliance
Adhere to Fujifilm Diosynth procedures and regulatory requirements for supplier quality management
Support supplier audit preparations and post-audit responses, process supplier complaints and change notifications, assist client audit requests with site documentation gathering.
QA representative to external suppliers
Interface and coordinate with sister sites on supplier quality system, harmonization, and joint qualification
Maintain approved supplier list
Process/track complaints to suppliers
Develop and issue weekly and monthly metric reporting on supplier performance
Provide audit support when needed
Participate in Material Review Board (MRB) review of nonconforming product; recommend disposition and corrective action.
Ensure no overdue training, or site actions. Support other QA teams and other functions in the completion of site actions.
New Business Growth
Work cross-functionally with various areas within the organization to uphold supplier quality requirements and standards.
Support client due diligence and Quality audits as well as regulatory inspections.
Work with Quality management to implement and grow phase-appropriate quality systems that will enable cGMP manufacturing of pre-clinical to commercial products.
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.
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.
Qualifications:
High School or equivalent: Seven (7) years or more of Pharmaceutical or other Regulated Industry experience.
Associates Degree: Three (3) years or more of Pharmaceutical or other Regulated Industry experience.
Bachelor's Degree.
Some exposure to good documentation practices, cGMP/GLP regulations.
Preferred Qualifications:
Degree in Biology, Chemistry or Engineering
Six Sigma Green/Black Belt cGMP experience.
cGMP experience.
Join us! FDB is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers - driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large.
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 979-431-3500.