Quality Assurance

CAPA PROGRAM/INVESTIGATIONS

At BEPC, our mission is to provide our medical device, pharmaceutical, and biotech clients with innovative consulting services focused on continuous improvement through the implementation of Six-Sigma, Lean and other related methodologies at an exceptional value. As part of BEPC’s comprehensive Quality Assurance/Quality Systems portfolio, we connect clients with professionals that have extensive Corrective Action Preventive Action (CAPA) experience, change management, and quality assurance engineering experience.

An effective, compliant CAPA Program is critical to the long term success of any Medical Device, Pharmaceutical or Biotech company.  At BEPC, we have access to professionals that have proven experience:

Subject Matter Experts that

  1. Design a new, cutting edge CAPA program
  2. Re-vamp an existing CAPA program
  3. Review and critique existing/submitted CAPAs
  4. Lead/execute CAPA investigations

 


CHANGE MANAGEMENT SPECIALIST

An effective Change Management Specialist is a critical member of any Medical Device, Pharmaceutical or Biotech company.  At BEPC, we have access to Change Management Specialists that have proven experience:

 

Subject Matter Experts that have/are

 

  1. A solid understanding of how people go through a change and the change process
  2. Experience and knowledge of change management principles, methodologies and tools
  3. Exceptional communication skills – both written and verbal
  4. Excellent active listening skills
  5. Ability to clearly articulate messages to a variety of audiences
  6. Ability to establish and maintain strong relationships
  7. Ability to influence others and move toward a common vision or goal
  8. Flexible and adaptable; able to work in ambiguous situations
  9. Resilient and tenacious with a propensity to persevere
  10. Forward looking with a holistic approach
  11. Organized with a natural inclination for planning strategy and tactics
  12. Problem solving and root cause identification skills
  13. Able to work effectively at all levels in an organization
  14. A team player and able to work collaboratively with and through others
  15. Acute business acumen and understanding of organizational issues and challenges
  16. Familiarity with project management approaches, tools and phases of the project lifecycle
  17. Experience with large-scale organizational change efforts

 


 

QUALITY ASSURANCE ENGINEERING PROFESSIONAL

An effective QAE Professional is a critical member of any Medical Device, Pharmaceutical or Biotech company.  At BEPC, we have access to QAEs that have proven experience:

Subject Matter Experts that:

  1. Determine quality improvement parameters by identifying statistical methods relevant to manufacturing processes
  2. Establish statistical confidence by identifying sample size and acceptable error; determining levels of confidence
  3. Develop experiments by applying full and fractional factorial techniques
  4. Maintain statistical process controls for multi-stream processes
  5. Analyze data by completing hypothesis, normal distribution, and process capability analysis tests
  6. Perform nonconformance and/or complaint evaluations and investigations
  7. Prepare reports by collecting, analyzing, and summarizing data; making recommendations
  8. Collaborate with QA/RA partners to:
  • Develop and improve documentation processes for in-house product design control and development, and production and process control activities, including supplier quality management, document change processes, process verification and validation, CAPA, risk management, and employee training programs

At BEPC, we pride ourselves in identifying and connecting professionals to Clients who are critical thinkers, work with a sense of urgency, and are self-motivated.  With an international North American network of highly qualified consultants, BEPC is committed to fulfilling our clients’ Quality System QAE needs.