QA Analyst III
Company: FUJIFILM Holdings America Corporation
Location: College Station
Posted on: March 17, 2023
Job Description:
Overview
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. -
External US
College Station, Texas may be a small, university town, but the
lively cultural scene and local amenities make it a great place for
families as well as those who want the ease of small-town life and
the convenience of living close to the vibrant pulse of big cities.
Eighty-seven percent of Texas' population lives within a 180-mile
radius, so we are in the center of it all in Texas. And our site is
nestled in the hub of innovation, representing a source of pride
for the area.The Quality Assurance (QA) Analyst III, under minimal
direction, will be responsible for review and/or approval of basic
and technical documentation, drafting and reviewing of internal
Quality policies and procedures, performing product related
activities, performing Quality audit functions, performing product
release activities, identifying process and Quality System
improvements, and acting as a QA liaison internally and
externally.Reports to - - - - - - - - Senior
Manager/Supervisor/Director, Quality AssuranceWork Location - - - -
-College Station, TX -Travel - - - - - - - - - - - - - - - - - - -
- - - - As neededPrimary Responsibilities:
- Review and/or approve basic and technical documentation with
minimal supervisory oversight to include, but not limited to:
- Standard Operating Procedures
- Batch Production Records (completed and approval)
- Commissioning, qualification and validation protocols and
reports
- Deviation Reports
- Corrective Action/Preventive Action Plans
- Technical data review and approval
- QC data review and approval
- Drug Substance/Product Reports
- Trending QA data
- Draft and review internal Quality policies, procedures, and
reports.
- Perform inspection of final product containers and review
and/or approval of executed process records and data.
- Perform Quality audit functions to include, but not limited to:
- Audit of lab notebooks
- Audit of equipment logbooks
- Review of vendor, supplier, contract laboratory audit
questionnaires
- Lead vendor, supplier, contract laboratory and client
audits
- Identify process and Quality System improvement
opportunities.
- Provide daily guidance for the compliance of the QA department
to national and international standards and regulations.
- Support Regulatory, client, and internal audits.
- Act as QA liaison to internal Departments and external Client
Quality Groups and Vendor/Contract Laboratory Quality Groups.
- Promptly notify Senior Management of potential quality or
regulatory issues that may affect product quality or regulatory
compliance.
- Assist with technical oversight/training for the QA team.
- Assist with compliance related functions.
- All other duties as assigned.
- Perform other duties as assigned.Qualifications:
- Master's Degree and 1+ years of experience in Pharmaceutical or
other regulated Industry.
- Bachelor's Degree and 3+ years of experience in Pharmaceutical
or other regulated Industry.
- Associates Degree and 5+ years of experience in Pharmaceutical
or other regulated Industry.
- High school or equivalent and 8+ years of experience in
Pharmaceutical or other regulated Industry.
- Certified Quality Auditor preferred.
- Degree in Biology or Chemistry preferred.
- 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.
- Ability to multitask and easily prioritize your 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.
- Management and GMP experience may be taken into consideration
in candidates with less years of Pharmaceutical / Regulated
Industry experience.
- Role model for company core values of trust, delighting our
customers, Gemba, and Genki.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.
- 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.
- Attendance is mandatory.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 979-431-3528.To all agencies: Please, no phone calls or emails
to any employee of FUJIFILM about this requisition. All resumes
submitted by search firms/employment agencies to any employee at
FUJIFILM via-email, the internet or in any form and/or method will
be deemed the sole property of FUJIFILM, unless such search
firms/employment agencies were engaged by FUJIFILM for this
requisition and a valid agreement with FUJIFILM is in place. In the
event a candidate who was submitted outside of the FUJIFILM agency
engagement process is hired, no fee or payment of any kind will be
paid.
Keywords: FUJIFILM Holdings America Corporation, College Station , QA Analyst III, Professions , College Station, Texas
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