Quality Assurance - Compliance Specialist III, Validation
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: March 17, 2023
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB) -The
work we do at FDB has never been more important-and we are looking
for talented candidates to join us. We are growing our locations,
our capabilities, and our teams, and looking for passionate,
mission-driven people like you who want to make a real difference
in people's lives. Join FDB and help create the next vaccine, cure,
or gene therapy in partnership with some of the most innovative
biopharma companies across the globe. We are proud to cultivate a
culture that will fuel your passion, energy and drive - what FDB
call Genki.Summary: - The Quality Assurance Compliance Specialist
III - QA Validation, will be responsible for the review and
approval of commissioning/qualification/validation protocols,
reports, computer automation validation protocols and final reports
and discrepancies for Quality Assurance. The QA Compliance
Specialist III - QA Validation, will handle all associated
responsibilities in compliance with Fujifilm quality policies and
site SOPs to ensure regulatory compliance.
- Provides QA support to the validation team during document
review to ensure the organization is complying with local and
global quality standards, regulatory requirements, and partner
- 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.
- Knowledge and understanding of Computer cGMP regulations and
practices pertaining to computer validation principles,
manufacturing processes, quality systems, engineering design
fundamentals, SOPs, regulatory agency expectations and industry
- Reviews computer test automation scripts, creation, and
deviation closure recommendations as required.
- Set up and maintain QA Validation Monthly TrackerNew Business
- Support client due diligence and Quality audits as well as
- 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
- 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 basis 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
- All other duties as assigned.Required Skills & Abilities:
- 5-10 years qualification/computer 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
- 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, weekends as
- Must be willing to travel occasionally, as needed.
- Attendance is mandatory.Qualifications:
- 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's 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. Preferred Qualifications:
- Degree in Biology, Chemistry or EngineeringWe 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 - Compliance Specialist III, Validation, Other , College Station, Texas
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