Quality Assurance - Risk Assessment Manager
Company: FUJIFILM Diosynth Biotechnologies
Location: College Station
Posted on: November 20, 2022
- The Quality Assurance (QA) Risk Management Manager position
will be responsible for providing leadership to the Texas site in
ICH Q9 principles of Risk Management. - Ability to facilitate risk
assessments, train future facilitators, provide oversight and
tracking of remediation actions, and communicate to leadership on
Essential Functions -
- Risk Management Delivery
- Support to the organization in leading the Risk Management
- Lead/facilitate Risk Management sessions
- Document and manage all Risk Assessments for the site
- Develop and issue weekly and monthly metric reporting
- Align Risk Management tools, ranking and filtering
- Manage Action item/Remediation activities
- New Business Growth
- 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.
- 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
- Understanding of biologic product life cycle as ICH Q8, Q9, and
- Experienced in FMEA, Fault Tree Analysis, Ishikawa Cause &
EffectWorking Conditions & Physical RequirementsThe 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
- 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 science-related field and 10 years'
- Associates degree with 12 years' of related experience
- 6 years cGMP experience
- At least 4 year's management or supervisory experiencePreferred
- 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
e-mail FDBTHR@fujifilm.com or call 979-431-3528.#LI-SB2
Keywords: FUJIFILM Diosynth Biotechnologies, College Station , Quality Assurance - Risk Assessment Manager, Executive , College Station, Texas
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