CAREERS

Controlled Environment Consulting, LLC is looking for a Quality Manager to join its world class team of controlled environment certification, design, and commissioning experts.  This individual should be a dynamic, high-energy professional who is looking for building a rewarding future in developing best-in-class quality systems and processes.

Location: This position will be based in Allentown, PA

Role and Responsibilities:

• Work HANDS-ON with the operations team, Training Coordinator and Project Engineers to develop and implement a Quality Management System QMS, Internal Auditing and CAPA process for our field services teams   
• Develop, establish, and monitor Key Performance Indicators (KPIs) and reporting based on the needs of business to support strategy and overall improvements 
• Conduct investigations to identify root cause of problems and implement effective corrective actions using structured processes
• Assist and lead internal audit program of the QMS and issue CAPA reports to improve and monitor the health of the QMS
• Review and approval of change controls, temporary change controls, Investigations and GMP documents (SOPs, work instructions, specifications, etc.)
• Ensure sustainment of implemented improvements through monitoring data trends
• Use a data-driven approach to achieve early problem identification and effective resolution
• Develop and conduct vendor auditing processes
• Participate in internal, regulatory and customer audits and customer visits at the discretion of management
• Provide regular reports and actively participate in service team
• Review, update, and manage internal test equipment calibration and maintenance programs
• Create and deliver relevant ongoing communications and metric scorecards to respective management, program teams and business teams
• Develop and oversee manual test report template control process

Skills and Experience:

• Bachelor’s degree in Science (BS/BA) from a four-year college or university, or five (5) years-related experience and/or training, or equivalent combination of education and experience
• Knowledge of FDA regulations including cGMP’s and current industry practice required
• Thorough knowledge of quality control/assurance and/or operations required
• Experience with quality oversight of GMP computer systems and data is preferred (building automation systems, serialization systems)
• Above average written and oral communication skills required
• Above average organizational and planning skills required
• ASQ CQE, CQMOE and/or CQA (Certified Quality Engineer/Auditor) certification is a definite plus