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Quality Assurance - Associate Analyst - Manufacturing Support

Employer
FUJIFILM Diosynth Biotechnologies
Location
College Station, TX
Start date
Oct 2, 2022

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Job Details

  The Quality Assurance (QA) Associate Analyst – Manufacturing Support, under direct supervision, will be responsible for assisting with the review and/or approval of basic documentation; Assisting with product related activities; Assisting with Quality audit functions; Identifying process and Quality System improvements; Review of manufacturing documents such as Batch Records, Cleaning forms/records, Logbooks; Perform cleaning verification or other similar inspections of manufacturing rooms and support areas; Other activities as directed by the direct Supervisor.

External US

Essential Functions:

  • Support/execute QA on the Floor program.
  • Perform routine walkthroughs of the manufacturing suites partnering with manufacturing on suite maintenance, Quality best practice implementation and troubleshooting when problems arise.
  • Assist with review of basic documentation to include, but not limited to:
    • Standard Operating Procedures
    • Batch Records
    • Logbooks
    • Forms
  • Assist with inspection of final product containers and review and/or approval of executed process records and data.
  • Assist in Quality audits to include, but not limited to:
    • Audit of lab notebooks
    • Audit of equipment logbooks
  • Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
  • All other duties as needed.

 

Required Skills & Abilities:

  • Excellent written and oral communication skills
  • Excellent organizational, analytical, data review and report writing skills
  • Ability to adapt to frequent and rapid changes in the work environment and allocate, adjust and optimize time accordingly
  • Proficient in Microsoft Office
  • All candidates will 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 required to:

  • Experience prolonged sitting, some bending, stooping and stretching.
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
  • Lifting up to 25 pounds on occasion.
  • Ability to wear restrictive gowning for extended periods of time during periods of prolonged standing.
  • Attendance is mandatory.

Minimum Qualifications:

  • Associates degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field; OR
  • High School Diploma/GED with some previous work experience.

 

Preferred Qualifications:

  • ASQ Certification
  • Knowledge of GMP/GLP regulations

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 email FDBTHR@fujifilm.com or call 979-431-3528.

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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