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Quality Assurance – Sr. Compliance Specialist – Deviations and CAPAs

Employer
FUJIFILM Diosynth Biotechnologies
Location
College Station, TX
Start date
Sep 30, 2022

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Discipline
Clinical, Clinical Medicine, Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Lone Star Bio
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Job Details

  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 reporting

New 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 requests

Compliance

  • 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 experience

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 979-431-3500.

 

Company

FUJIFILM Diosynth Biotechnologies is an industry leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting our partners in the biopharmaceutical industry with the development and production of their biologic, vaccines and gene therapies.

With over 30 years of experience in process development and cGMP manufacturing, a dedicated staff of over 2,000 and a reputation for excellent customer service, flexibility and responsiveness, we’ve become a trusted partner to some of the most prominent biotech developers and pharmaceutical companies in the industry.

Our Process Development experience includes the development of processes for molecules expressed via fermentation (e.g., E. coli, P. pastoris), cell culture systems including CHO, HEK, Vero, MDCK, EB66 and insect cells, and from transgenic sources.

Our network expands within five development and manufacturing facilities located in Teesside, United Kingdom; Research Triangle Park, North Carolina, USA; College Station, Texas, Thousand Oaks CA USA and Hillerød, Denmark.

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Find Us
Website
Phone
919-337-4400
Location
Thousand Oaks, CA
Research Triangle Park, NC
College Station, TX
Holly Springs, NC
Watertown, MA
United States
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