Quality Assurance - Associate Analyst - Manufacturing Support
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: May 6, 2022
Job Description:
Overview Summary: - 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
productsWorking 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 regulationsWe 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 - Associate Analyst - Manufacturing Support, Professions , College Station, Texas
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