Quality Assurance Manager

Employer: Polymer Solutions
Job Location: Christiansburg, Virginia
Category: Quality Assurance
Employment Type: Full Time
Last Updated: 9/25/2018
Closing Date: 12/31/2018
Polymer Solutions
Since 1987, Polymer Solutions (PSI) has been answering difficult questions regarding polymers, plastics and composites. From our home in Blacksburg Virginia, we partner with our clients from around the world to solve and prevent their most complex problems through chemical analysis, physical testing and consultation.


http://www.polymersolutions.com
Job Description  
 
Position:  Quality Assurance Manager
 
Description: Administrate and develop the quality system at PSI based on ISO/IEC 17025, and 21 CFR, Parts 11, 210, 211, 610 and 820. Promote continuous improvement of laboratory and business systems with respect to quality. Be the face of quality for SGS Polymer Solutions Incorporated.
Essential Functions:
  • Lead the ISO/IEC 17025 and 21 CFR, Parts 11, 210, 211, 610 and 820 Quality System at Polymer Solutions Incorporated as a system of continuous improvement.
  • Responsible for ensuring IT, Facilities, and the Labs are 21 CFR Part 11 Complaint during equipment qualification process and through regular data integrity audits.
  • Give leadership and develop the quality system with the Qualtrax Document Management System as a tool for achieving ISO/IEC 17025 requirements and the cGMP compliance at PSI.
  • Provide quality approval for all documentation related to work instructions.
  • Provide one of two approvals for all approvals related to Quality Procedures or major system changes.
  • Lead and administrate the Qualtrax Document Management system.
  • Oversee the schedule, training, execution and, closing of the Internal Audits each year.
  • Oversee all non-conformances resulting from Internal and External Audits, Complaints, OOS’s and any other investigations ensuring that the system is suitable for compliance and business practice.
  •  Execute all quality agreements or quality surveys sent by the customer.
  • Lead all customer audits or regulatory body audits representing SGS Polymer Solutions Incorporated and providing the required documentation, interaction, and completion of any resulting actions. 
  • Interact with SGS PSI staff as necessary to ensure that all quality requirements are understood and executed through effective communication and training.
  • Oversee the Quality Control System including leadership of any changes or improvements.
 Minimum Requirements:
  • Experience in an ISO/IEC 17025 laboratory setting is required.  Experience in a cGMP environment is required.
  • Bachelor’s degree in Chemistry or other relevant science with at least five years of experience in a directly relevant setting.
  • Team Management experience  
Competencies:
  • Adaptability - the individual adapts to changes in the work environment, manages competing demands and is able to deal with frequent change, delays or unexpected events
  • Communication - the individual discusses issues and asks questions in a direct and organized manner with the intention of aiding in the delivery of and documentation of pertinent information
  • Computer Skills - the individual is experienced in the use of standard computer programs including Windows, Outlook, Word, PowerPoint, and Excel and is quick to learn the use of new programs with training and self learning
  • Customer Service - the individual exhibits a helpful, polite, professional but friendly manner when interacting with internal customers, suppliers, or potential customers of PSI
  • Interpersonal Skills - the individual maintains confidentiality, remains open to others’ ideas and exhibits willingness to try new things
  • Leadership – the individual exhibits confidence and shows a willingness to take ownership of their responsibilities setting a good example for others to follow
  • Organization - the individual maintains an organized work environment and uses and improves systems to benefit the company and other staff members
  • Planning/organizing - the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans
  • Problem solving - the individual identifies and resolves problems in a timely manner and gathers and analyses information skillfully
  • Quality Control - the individual understands and works within the PSI quality system in the performance of all work and demonstrates accuracy and thoroughness and monitors own work to ensure quality    
  • Safety and Security - the individual actively promotes and personally observes safety and security procedures and requirements, and uses equipment and materials properly
  • Trust - the individual exhibits trust in and respect for management and co-workers regarding professional interactions
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