Quality Control - Stability Coordinator II
Company: FUJIFILM Holdings America Corporation
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 II 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 II, 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
- Follow all established laboratory, regulatory, safety, and
environmental procedures
- Maintain and execute a minimum of 8 stability protocols
- Provide technical suggestions to customers based on industry
guidelines
- Follow all established laboratory, regulatory, safety, and
environmental procedures
- 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 in 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 -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
- 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 6 years' experience between
coordinator/management position and 1 year in a GxP setting;
OR
- Associates degree and minimum of 4 years' experience between
coordinator/management position and 1 year in a GxP setting;
OR
- Bachelor's degree and minimum of 2 years' experience between
coordinator/management position and 1 year in a GxP setting;
OR
- Master's degree and minimum of 1 year experience between
coordinator/management position and 1 year in a GxP
setting.Preferred Qualifications:
- Bachelor's degree in a scientific discipline
- PMP Certificate
- Analytical background
- Client relations background -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
or call 979-431-3500.
Keywords: FUJIFILM Holdings America Corporation, College Station , Quality Control - Stability Coordinator II, Other , College Station, Texas
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