Quality Assurance Specialist, Data Integrity
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 13, 2022
Summary : - The Quality Assurance (QA) Specialist for Data
Integrity will be responsible for the day to day running of the
FDBT Data Integrity Program, performing data integrity assessments,
gap confirmation and risk assessments, in addition to supporting
client and regulatory audits (when required).
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.
Act as an ambassador for FDBT Quality Culture.
Deputize fronting Data Integrity in customer and regulatory audits
New Business Growth
Work with Quality management to implement quality systems that will
enable cGMP manufacturing of pre-clinical to commercial
Work as a change agent to compliantly improve existing or introduce
new ways of working.
Ensure smooth operation of the FDBT Data Integrity program
highlighting any issues in a timely manner.
Provide guidance and advice to ensure Data Integrity remediation
actions are successfully completed.
Engage in global FDB projects and meetings (as required).
All other duties as assigned.
Required Skills & Abilities:
Ability to collaborate effectively with stakeholders from across
the business, at all levels.
Excellent written and oral communication skills.
Excellent organizational, analytical, data review and report
Ability to set personal performance goals and provide input to
Develop staff to maximize contributions to the team and the
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
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
Must be willing to travel occasionally, as needed.
Attendance is mandatory.
Bachelor's degree with 2 years of related experience OR
At least 4 years of cGMP experience.
Involvement in Data Integrity projects during previous roles
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
If an accommodation to the application process is needed, please
email FDBTHR@fujifilm.com or call 979-431-3528.
Keywords: FDBT - FUJIFILM Diosynth, College Station , Quality Assurance Specialist, Data Integrity, Other , College Station, Texas
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