Job Description Template - Vesta Therapeutics
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1
2
3JOB DESCRIPTION TEMPLATE
Title:
Head of Quality Control
Reports To:
Chief Operating Officer
Department:
QC
Date:
1 June 06
Work Location:
NC
Submitted By:
OBJECTIVE
Accountable for set-up, oversee and report the maintenance of quality control during production of
a quality cellular product according to GMP regulations.
ESSENTIAL DUTIES/RESPONSIBILITIES
1.
Responsible for directing and overseeing the planning, implementation and maintenance of
quality control methods, processes and operations for existing products and technologies.
2.
Manage resources for the analysis of products, meeting timelines, quality and quantity standards.
3.
Familiar with, and able to teach analytical techniques, standard laboratory practices and cGMP
guidelines.
4.
Responsible for collaboration with manufacture functions to ensure all production processes
comply with GMP.
5.
Responsible for training process of all GMP employees.
6.
Responsible for maintaining department training files.
7.
Provide guidance to effectively resolve deviations and out-of-specification results and work
closely with Head of Production to develop plans for investigations and corrective actions.
8.
Assess process optimizations/improvements
9.
Ensure continuous improvement by identifying emerging trends, technologies, and best practices
and incorporate into operations, where applicable.
10.
Coordinate monthly reports and/or updates as they relate to QC activities and completion of
projects (validation, tech transfers, etc.)
11.
Design and review/approve SOPs, test procedures, process validation protocols and reports, etc.
12.
Frequently interact with subcontractors and functional peer group managers.
Prepared By: __________________________
Date:_____________
Supervisor:
__________________________
Date:_____________
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Parent category: Business