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