Quality Assurance Specialist, Data Integrity
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: June 20, 2022
Overview 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). - External
US Essential Functions:
- 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.
- Compliance Delivery
- Deputize fronting Data Integrity in customer and regulatory
audits (as required).
- 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
- 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 manufacturing activities.
- Must be willing to travel occasionally, as needed.
- Attendance is mandatory. -Qualifications:
- Bachelor's degree with 2 years of related experience OR
- At least 4 years of cGMP experience. - -Preferred
- Involvement in Data Integrity projects during previous rolesWe
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.
Keywords: FDBT - FUJIFILM Diosynth, College Station , Quality Assurance Specialist, Data Integrity, Other , College Station, Texas
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