Quality Assurance - Sr. Compliance Specialist - Deviations and CAPAs
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: March 13, 2023
Job Description:
Overview
Summary: - The Quality Assurance - Sr. Compliance Specialist, will
be responsible for supporting performance of the Quality Systems
group. - The Specialist will assist with the tracking and
coordination and closure Change Control records, investigations,
and all associated responsibilities in compliance with Fujifilm
quality policies and site SOPs to ensure regulatory compliance.
-
External US
Essential Functions:Compliance Delivery
- Support to the organization in coordinating and closing Change
Controls, to be on-time
- Develop and issue weekly and monthly metric reportingNew
Business Growth
- Support client due diligence and Quality audits as well as
regulatory inspections.
- Work with Quality management to implement and grow
phase-appropriate quality systems that will enable cGMP
manufacturing of pre-clinical to commercial products.
- Support client audit requestsCompliance
- Ensure self, and team, have no overdue training, or site
actions. Support other QA teams and other functions in completion
of site actions.
- Provide cGMP assistance to other functions such as
Manufacturing, Facilities and QC.
- Promptly notify Senior Management of potential quality or
regulatory issues that may affect product quality or regulatory
compliance -Leadership
- 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.
- Mentor peers towards achieving organizational and individual
goals.
- All other duties as assigned.Required Skills & Abilities:
- 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 work.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
stretching.
- 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 preferably in a science-related field with 6
-8 years of related experience
- At least four (4) years of cGMP experience in a
Quality/Compliance role.Preferred Qualifications:
- Certified Quality Auditor
- Degree in Biology, Chemistry or Engineering
- Supervisory/leadership experienceWe 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
or call 979-431-3500.
Keywords: FDBT - FUJIFILM Diosynth, College Station , Quality Assurance - Sr. Compliance Specialist - Deviations and CAPAs, Other , College Station, Texas
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