Quality Assurance Specialist, Auditor
Location: College Station
Posted on: March 15, 2020
OverviewSummary:-- The Quality Assurance (QA) Specialist for
Audit & Inspection will be responsible for supporting and client
audits, regulatory inspections, conducting internal and supplier
assurance audits. External USEssential 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.
- Compliance Delivery
- Support to the organization in conducting internal and supplier
audits and hosting audits/inspections.
- New Business Growth
- Work with Quality management to implement quality systems that
will enable cGMP manufacturing of pre-clinical to commercial
- Support the external and internal Audit Programs to be in an
acceptable state of compliance.
- Responsible for audit preparations, conducting internal audits,
assisting client audits with site documentation gathering, leading
war room when required.
- Support Global Supplier Assurance - work with the global team
to participate and represent Texas Site in supporting joint
- All other duties as assigned.----Required Skills & Abilities:--
- Travel will be required for conducting supplier audits
- 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:
- Bachelors degree with 2 years of related experience OR
- Associates degree with 4 years of related experience
- At least 4 years of cGMP experience.--Preferred Qualifications:
- Certified Quality Auditor
- Degree in Biology, Chemistry or Engineering--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 e-mail FDBTHR@fujifilm.com or call 979-431-3528.
Keywords: Fujifilm, College Station , Quality Assurance Specialist, Auditor, Accounting, Auditing , College Station, Texas
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