Quality Control - Stability Coordinator III
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 QC Stability Coordinator III, will
construct, maintain, and oversee the Quality Control Testing of
Stability programs to include developing a schedule of pull dates,
overseeing testing of each pull, and generating summaries from the
data. -The Quality Control Coordinator III, under general
direction, will be responsible for implementing a Quality Control
Stability Program that will encompass the needs of the client for
each program. The position will require frequent communication with
the Chemistry, Cell Biology, Microbiology, and Quality Assurance
groups to coordinate execution of testing, deviation management,
and issuance of deliverables. The Coordinator will have visibility
to method qualification to ensure timing of stability laydowns.
Close attention to detail is required to oversee and compile the
stability testing and data, to facilitate meeting deadlines and
milestones. Other responsibilities may include but are not limited
to: ownership of CAPA's and deviations, client meetings, attending
planning meetings, communication of changes, and utilizing new
software.
External US
Essential Functions:
- Assists in preparing QC metrics on a monthly basis
- Performing pulls occur within the specified window
- Ensuring testing occurs within the specified window
- Assist in generating POs for external testing
- Work directly with Contract laboratories to coordinate and
monitor testing and release schedules
- Work directly with customers to update and confirm schedules
and deadlines
- Attend daily briefings and update as needed
- Assist QC Director and QC Managers
- Ability to work cross functionally with other Quality Control
groups, Quality Assurance, Manufacturing, and Project Management to
establish timelines
- Establish GMP documentation
- Review GMP documentation
- Update GMP documentation
- Maintain and execute a minimum of 10 stability protocols
- Provide technical suggestions to customers based on industry
guidelines
- Follow all established laboratory, regulatory, safety, and
environmental procedures
- Performs deviation management
- Perform contract reviews
- Perform other duties as assignedRequired Skills & Abilities:
- Must be highly organized, driven, and possess the skills and
capability to plan ahead and stay on schedule
- Ability to evolve and adapt to new technologies to include
electronic planning tools and Laboratory Information Management
Systems (LIMS)
- Computer skills a must-Microsoft Office and Microsoft
Project
- Ability to multi-task and prioritize work assignments with
little supervision
- Excellent attention to detail
- Ability to work in a team or independent setting and
collaborate with employees from various departments
- Excellent analytical and planning skills
- Must have excellent organizational, written and oral
communication skills
- Possess excellent customer service and interaction
skillsWorking 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.
- Use hand-eye coordination and manual dexterity sufficient to
operate a keyboard, photocopier, telephone, calculator, and other
office equipment is required.
- Ability to sit for long periods to work on a computer.
- Attendance is mandatory.Minimum Qualifications:
- High school or GED and minimum of 8 years' experience between
coordinator/management position and 2 years in a GxP setting;
OR
- Associates degree and minimum of 6 years' experience between
coordinator/management position and 2 years in a GxP setting;
OR
- Bachelor's degree and minimum of 4 years' experience between
coordinator/management position and 2 years in a GxP setting;
OR
- Master's degree and minimum of 2years' experience between
coordinator/management position and years in a GxP
setting.Preferred Qualifications:
- Bachelor's degree in a scientific discipline
- PMP Certificate
- Analytical background
- Client relations background
- Customer interaction training
- Lean Six Sigma training or a similar process improvement
trainingWe 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 or call 979-431-3500.
-#LI-SB2
Keywords: FDBT - FUJIFILM Diosynth, College Station , Quality Control - Stability Coordinator III, Other , College Station, Texas
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