Quality Manager

Position Description
Oversight and responsibility to ensure effectiveness of Etowah site:

• Quality management system
• Facilities and equipment systems
• Materials system
• Production system
• Packaging and labeling system
• Laboratory control system

To meet all relevant regulatory requirements and conform to expectations of key customers.

• GMP resource and implementation leader for the Etowah site, to include:
• managing GMP inspections program
• developing content and delivering GMP orientation and annual  refresher training for all employees. 

With Operations management, conduct formal assessment of Etowah facility and systems vs Silica Global GMP Policy and identify any gaps.  Lead development of improvement actions to address and/or document justification for exception based on risk assessment

• Owner of responses to customer feedback, to include:
• ensure all complaints are entered into CATSWeb
• timely assignment of investigations to appropriate, qualified individuals
• ensure 1st hand contact to customer at initiation of investigation to get additional information and provide assurance of concern
• support investigations to timely completion
• complete CAPA stage of complaint response to include verification of completion of planned actions and effectiveness
• keep Sales informed of progress throughout

Lead site Quality group.  Ensure clarity of roles and coordination of efforts for all levels and positions.  Set goals for the group and monitor measured improvement.  Foster open communication, proactively resolve issues, and develop people.

Monitor production process, product quality and serve as final release authority for any atypical events or results.  Ensure appropriately rigorous processes are established for OOS investigations and product release

• Promote and ensure effective corrective and preventive actions across the site, including:
• use of Quality Incident Alert process to document quality issues and near hits
• identification of root causes as part of follow-up and development of corrective actions
• documented tracking of issues and corrective actions to completion
• analysis of issues for input to North America Silica (NAS) management review

Involvement in supplier qualification and ongoing evaluation programs, including coordination of new ingredient trials and evaluation of results, serving as quality representative on supplier site audits, decisions on requests for specification exceptions, review of suppliers' response to Quality Advisement Notices

Lead validation program for Etowah site, to include

• revisit Validation Master Plan, clarify systems to validate and achievable schedule
• utilize established format / approach to validation and qualification protocols or develop more appropriate alternative and present for use across NAS
• work with engineering and operations to develop practical approaches for validations per plan, serve as approval for all validation protocols and reports
• apply IPEC significant change evaluation principles in assessing all proposed changes, serve as quality approval per change mgmt. procedure

Position Requirements

• Bachelor or Master degree in applicable discipline, significant coursework in chemistry and/or chemical engineering preferred, or equivalent combination of education, credentials and experience
• Demonstrated experience in quality management position(s) to demonstrate technical capabilities, leadership and influence skills
• ASQ certification desired – CQM/OE (preferred),CQE and /or CQA
• Proficiency in ISO 9000 series of standards for quality management systems and IPEC-PQG Good Manufacturing Practices (GMPs)
• Demonstrated experience in successful application of quality improvement tools such as root cause analysis, Ishikawa or ‘fish- bone’ diagrams, FMEA, 6-sigma DMAIC model, process capability analysis, SPC, etc. to process improvement and problem solving