Quality Assurance - Analyst II
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: March 17, 2023
Job Description:
Overview
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB) -The
work we do at FDB has never been more important-and we are looking
for talented candidates to join us. We are growing our locations,
our capabilities, and our teams, and looking for passionate,
mission-driven people like you who want to make a real difference
in people's lives. Join FDB and help create the next vaccine, cure,
or gene therapy in partnership with some of the most innovative
biopharma companies across the globe. We are proud to cultivate a
culture that will fuel your passion, energy and drive - what FDB
call Genki.Summary:The Quality Assurance (QA) Analyst II, under
general direction, will be responsible for review and/or approval
of basic and technical documentation; Drafting and reviewing of
internal Quality policies and procedures; Assisting in and
performing product related activities; Assisting in and performing
Quality audit functions; Identifying process and Quality System
improvements; Acting as a QA liaison internally.
External US
Essential Functions:
- Review basic and technical documentation to include, but not
limited to:
- Standard Operating Procedures
- Analytical Methods
- Disposition certificates
- Batch Production Records
- Corrective Action/Preventive Action Plans
- QC Data review
- Technical Data Review
- Drug Substance/Product Reports
- Review internal Quality policies, procedures and reports
- Assist in and perform Quality audit functions to include, but
not limited to:
- Audit of lab notebooks
- Audit of equipment logbooks
- Act as a QA liaison to internal Departments and Vendor/Contract
Laboratory Quality Groups
- Notify Supervisor 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 set personal performance goals and provide input to
departmental objectives
- Ability to adapt to frequent and rapid changes in the work
environment and allocate, adjust and optimize time accordingly
- Ability to work independently and establish work priorities to
meet targets and timelines
- Proficient in Microsoft Excel, Word and PowerPoint
- 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.
- 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
with this position.
- 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.
- Lifting up to 25 pounds on occasion.
- Ability to wear restrictive gowning for extended periods of
time during periods of prolonged standing.Management and GMP
experience may be evaluated in candidate with less years of
Pharmaceutical / Regulated Industry experience.
- Attendance is mandatory.Qualifications:High School or
equivalent: - 6 years or more of Pharmaceutical or other Regulated
Industry experience. Associates Degree: 4 years or more of
Pharmaceutical or other Regulated Industry experience. Bachelor's
Degree: - 2 years or more of Pharmaceutical or other Regulated
Industry experience.Master's Degree: - 1 year or more of
Pharmaceutical or other Regulated Industry experience. Preferred
Qualifications:
- ASQ Certification
- Degree in Biology or ChemistryWe 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 - Analyst II, Professions , College Station, Texas
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