Job Description Summary

Job Description

As directed by the Manger, Quality, Distribution Operations, the Staff Engineer, Distribution Quality is accountable for working cross functionally in the development, assessment, qualification and improvement of Distribution processes.

Primary Responsibilities and Duties:

• Responsible for Quality processes as assigned including, but not limited to Change Control, CAPA, CI, Risk Management and Validation.                            
• Applies analytical methods and statistical techniques in evaluating process and service provider performance.
• Works within and across functions for process development, maintenance, improvement and issue resolution. Develops solutions to routine assigned activities of moderate scope & complexity.
• Consistent application of Quality System standards to Quality processes.
• Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements.
• Follows applicable Company / Unit procedures and may make updates to procedures and policies.

Position-Specific Overview:

• Partner and effectively collaborate across functions and sites to address and/or improve Distribution performance as the Subject Matter Expert(SME), trainer and owner of the following Quality Systems:
  • Change Control, including leadership of the local Change Control Board, and associated records.
  • CAPA, including leadership of the local CAPA Council and site representation on the Regional CAPA Council, Trackwise for CAPA and process metrics.
  • Validations and Qualifications, including the protocol development, execution and records.
  • Risk Assessment, as applicable to the above in addition to maintenance of the local Risk Management File.
  • Analysis of Data, through analytical methods and statistical techniques that support and/or measure performance, investigations, sample planning, improvements, corrective actions, preventive actions, implementations and effectiveness.
  • Other duties and responsibilities as assigned.

Scope of Responsibility:

Strategic Orientation:

• Maintain compliance and effectiveness of assigned Quality Processes as a SME, trainer, mentor and partner to Distribution functions.
• Ensures accuracy of Quality metrics and analytics supporting appropriate assessment of assigned processes within local and regional Management Review.
• Represents local site during regional process meetings, communicates resolutions to issues to prevent occurrences at other sites and assess learnings/best practices from other sites for applicability to local site.
• Maintain awareness and working knowledge of industry and Corporate requirements to ensure site compliance.
• Contributes to the completion of specific programs and projects within and across functions.

Sphere of Influence:

• Work is performed without appreciable direction. 
• Assignments are often self-initiated.  Determine and pursue courses of action necessary to obtain desired results.
• Plans and participates in disciplines strategically relevant to the business and/or functions
• Provides advice and mentors functional leaders and associates to promote a culture of Quality and customer experience improvement.
• Participates in, and may provide  leadership for, multi-disciplinary projects
• Considered Site / Functional  Subject Matter Expert (both process & IT applications) for assigned quality system/s
• May be assigned  as Site / Functional member of Quality Systems Network team  for assigned Quality systems element

Impact on Business Results:

• Decisions, recommendations and results cause moderate progress in key driver goals and schedules
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions to problems with broad scope and complexity
• Failure to obtain results or erroneous decisions would result in serious project / key driver goals.

KSA Requirements (Knowledge, Skills, and Abilities):

• Knowledge:  Consistent application of Quality system standards to assigned Quality system area.
• Working Knowledge of Quality Systems Regulatory requirements, including ISO 13485 and 21 CFR 820, and  their application to Company /Unit requirements
• Skills:  Excellent communication, problem solving, organizational, project management and interpersonal skills are essential.
• Proficient in data tracking and trending and the software program/s associated with these.
• Education/Degree:  Bachelor’s Degree in Quality Engineering or related Science preferred, including experience in a regulated or Supply Chain industry.
• Certificates:  CQE, Green and/or Black belt certification/s preferred, but not required. 
• Experience:  A minimum of 8 years relevant experience in Pharmaceutical, Medical Device or Supply Chain industry, or a combination of equivalent education and relevant experience in a Quality role. 
• Other:  Computer skills (Excel, Word, Power Point, Minitab, etc.) 
• Independently determines and develops approach to solutions.
• Demonstrated ability to work in teams to obtain results is required.

Primary Work Location

USA IN - Plainfield

Additional Locations

Work Shift