Quality Assurance - Document Control Manager
Company: FUJIFILM Diosynth Biotechnologies
Location: College Station
Posted on: November 19, 2022
This is an experienced person with in depth and specialized
knowledge of cGMP documentation. This position can largely function
with minimal or no supervisory oversight for routine duties such as
document routing, tracking document review and approval process,
assessing document related training requirements and tracking
training. Additionally, they have sufficient knowledge and
experience to establish and modify comprehensive document control
systems which are compliant with cGMP requirements. They may be
assigned duties representing Quality in appropriate situations as
defined by their management. External US Essential Functions
- Defines the policies/procedures for document control
- Ensure adequate staff levels to meet work goals per schedule
- Managing staff/project related budgets
- Client Audit team DC representative (in room with client
- Regulatory Audit Team representative (in room with regulatory
- Liaising with clients regarding DC approvals/business process
- Provide strategy for business related projects (process
- Represent DC in business teams meetings
- Represent FDBT DC in Global meetings
- Change Control, Deviation and CAPA management
- Writing and revising QA SOP's
- Training, motivating and guiding staff and new hires
- Resolving staff issues and delivering performance reviews
- All other duties as assigned Required Skills & Abilities
- Excellent written and oral communication skills
- Excellent organization
- Experience with Word, Excel, and Adobe
- Working Conditions & Physical RequirementsThe 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
- Experience prolonged sitting, some bending, stooping and
- Use hand-eye coordination and manual dexterity sufficient to
operate a keyboard, photocopier, telephone, calculator, and other
office equipment is required.
- Ability to access and utilize computer interfaces for extended
periods of time.
- Attendance is mandatory.
- On call availability during some off hoursQualifications
- High school or equivalent 10 years or more experience in
Pharmaceutical or other regulated Industry.
- Associates Degree 7 years or more experience in Pharmaceutical
or other regulated Industry.
- Bachelor Degree 5 years or more experience in Pharmaceutical or
other regulated Industry.
- Master's Degree 2 year or more experience in Pharmaceutical or
other regulated Industry.
- Supervisory experience 4 years
Keywords: FUJIFILM Diosynth Biotechnologies, College Station , Quality Assurance - Document Control Manager, Executive , College Station, Texas
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