The position is responsible for the following:
Writes, reviews, approves and/or executes documentation for new and current validation procedures and technical
reports related to systems, products and/or processes.
Conducts quality control for statistical analyses of testing results and process anomalies.
Ensures that corrective measures meet acceptable reliability standards.
Verifies calibration, maintenance and repair of instruments as applicable to support the Quality Systems validation
program.
May evaluate quality and system standards to ensure reliability and compliance with company standards and
government regulatory requirements.
Education
Bachelor's Degree in Sciences or Engineering or equivalent combination of education, training and
relevant work experience required
ASQ Certification preferred
Experience
0-3 years' related quality/validation experience in pharmaceutical manufacturing/a highly regulated
industry
In-depth working knowledge of cGMP principles and applications
Demonstrated ability writing and approving documents, which help explain technologies, processes
and products including validations
Participating in FMEA or RCA/CAPA development teams
Additional
Comments
Understand regulatory standards, various local, state and federal laws that apply to the business
and where to find information on standards and interpretations
Excellent negotiating, critical reasoning, decision-making, and problem solving skills to analyze
situations, determine risks, find solutions to prevent future issues and resolve recurring defects
Strong project management and organizational skills and attention to details to handle multiple
tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company
objectives
Strong written and verbal communication, interpersonal and presentation skills to drive results
Establish solid working relationships to interface with other business units, third parties and other
positions and circumstances within the organization
Demonstrates excellent customer service skills with the flexibility to respond to changes quickly
Maintain a professional demeanor and handle confidential information with discretion
Computer literate with proficiency in office applications, word processing, spreadsheets, graphics
and statistical programs, and use of electronic quality and operational systems
Working
Conditions
(physical &
mental
requirements)
Understands complex problems to collaborate and explore alternative solutions
Ability to make decisions which have significant impact on the immediate work unit and monitor
impact outside immediate work unit
Attention to detail and ability to follow written and verbal directions in exact detail required
Work in fast paced environment with frequent interruptions
Approximately 80% of time spent sitting to complete job duties
No overnight travel required
