Quality Assurance - Compliance Specialist II
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 12, 2022
Overview Summary: - The Quality Assurance (QA) Specialist of
compliance, 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.
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
- Support client due diligence and Quality audits as well as
- 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
- All other duties as assigned.Required Skills & Abilities:
- Excellent written and oral communication skills.
- Excellent organizational, analytical, data review and report
- Ability to set personal performance goals and provide input to
- 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 in a related science concentration with 2
years of experience of cGMP supporting pharmaceutical or
biotechnology products; OR 1 year experience with FDB with a
- Associate's degree in a related science concentration with 4
years of experience in a regulated industry, including 2 years of
experience of cGMP supporting pharmaceutical or biotechnology
- High School or equivalent: 6 years or more of Pharmaceutical or
other Regulated Industry experience.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 II, Other , College Station, Texas
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