Director of Quality Control - Job Number 1784
Date posted: June 26, 2008
Location: Research Triangle Park, NC
Job type: Full-time
Industry: Pharmaceutical
Description:
Due to our Clients success, they are expanding their leadership team and are seeking a highly motivated hands-on individual to plan, organize and manage the Quality aspects of the Company to ensure products meet all corporate quality standards, domestic and international standards, and state and government regulations. This is a unique opportunity to work with a venture capital-backed, growth-oriented technology company, with excellent learning, training and advancement potential. The Quality portion of the position will require the candidate to: -Develop and control all inspection procedures and documentation -Develop, conduct, and control product and process qualifications -Develop and control vendor certifications, corporate calibration programs, documentation controls and all GMP and Quality System Regulation programs and requirements. -Establish and maintain a Quality Plan which defines the quality practices, resources and activities relevant to products that are designed and manufactured by NCSRT Inc. -Oversee and conduct internal and external audits -Establish and maintain a CAPA program -Develop, maintain and report compliance-related functional metrics -Develop and administer Quality Systems training company-wide -Develop and administer budgets, schedules, and performance requirements for functional area -Prepare for and coordinate hosting of regulatory inspections -Perform other related duties as assigned
Qualifications:
-Quality Engineer with a biopharma background preferred. -ASQ certification desirable -B.S. degree, or equivalent, in engineering or life sciences with 5 years experience -Must have solid understanding of Quality System Regulations and ISO quality requirements. -Thorough working knowledge of design controls, validation principles, domestic and international standards. -Ability to understand sufficient knowledge of new or modified products such that validation protocols can be written prior to the completion of development of the products. -Write comprehensive reports in a timely manner. -Must be able to correctly interpret and apply domestic and international laws and standards to validation protocols, failure analysis and risk analysis. -Must be skilled at failure analysis, understand root cause analysis and be able to develop comprehensive trend and analysis reports. -Must have the skill sets necessary to design experiments for failure analysis, validation and reliability work. -Must have excellent written and verbal communication skills. -Strong interpersonal skills. -Must have working knowledge of Microsoft Office products. -Must be willing to travel.
For confidential consideration please submit a resume and salary history to Claire@fullscalesolutions.com
Full Scale Solutions is an equal opportunity employer.
Category: Pharmaceutical/Biotech
Company: Full Scale Solutions
Full Scale Solutions, Inc. is a Human Capital management company that provides exceptional recruiting solutions to companies to help them grow.