Job Description Summary

Job Description

As directed by the Manager, Quality, Distribution Operations.  The Quality Systems Specialist is accountable for working cross functionally in the application, understanding and compliance of their assigned Quality Systems.

Primary Responsibilities and Duties

• Responsible for Quality Systems as assigned,
• Responsible for application of assigned Quality Systems in a manner that meets the scope of storage and distribution processes.
• Responsible for monitoring assigned Quality System performance through established metrics and/or Quality objectives, addressing under performance and escalation with appropriate leadership when required.
• Collaborates with functional process owners to train, mentor and/or facilitate QMS requirements, continuous process improvement and audit support. 
• Maintains awareness, follows applicable Corporate Quality procedures and may make updates to procedures, policies, training matrixes and curriculums. 

Position-Specific Overview:

• The Quality Systems Specialist will be accountable for Quality Systems as the local Subject Matter Expert (SME), providing guidance and training, facilitating meetings, escalation and ensuring compliance to the following Quality Systems as assigned:
  • Document and record control, DMS Administrator
  • Training & Curricula / C2C DLA / GMP & GDP
  • Order Fulfillment Claims support for root cause analysis and SCARs
  • Intracompany Claims
  • QMS Audits
  • Metric Data Analysis
  • Product Hold
  • Non-Conformance Administration
• Maintain awareness, train and mentor distribution functions as the SME for the Quality Systems assigned as well as applicable requirements from ISO 13485, 21 CFR 820 and Corporate Policies / Procedures when appropriate.
• Where assigned, responsible for ensuring site is meeting the terms and obligations of local wholesale drug licenses as the Designated Representative.
• Participate and represent Distribution Quality on projects, implementations and initiatives associated with regional improvement goals, annual Quality objectives, integration and optimization as assigned. 
• Other duties and responsibilities as assigned.

Scope of Responsibility:

• Ensures applicable Quality Systems comply with current ISO 13485, 21 CFR 820 and corporate requirements.   Ensures the accurate and actionable records for the making of decisions.
• Ensures distribution processes follows applicable released procedures.
• Contributes to long-range Supply Chain strategies, choosing disciplines and methods appropriate to the work content and context.
• Outputs contribute to reduced compliance risks, improved effectiveness and furthering the achievement of goals critical to company objectives

Sphere of Influence:

• Works under general direction.   
• Determine and pursue courses of action necessary to obtain desired results.
• Plans and participates in disciplines strategically relevant to the business and/or functions
• Participates in, and may provide  leadership for, multi-disciplinary projects
• Considered Site / Functional Subject Matter Expert (both process & IT applications) for assigned processes.
• May be assigned  as Site / Functional member of Quality Systems Network team  for assigned Quality systems element
• Sharing of best practices across local and regional sites and functions

Impact on Business Results

• Erroneous decisions or recommendations would typically result in failure to achieve critical organizational / functional objectives.
• Failure to maintain compliant Quality Systems could result in audit findings or breach of Quality Agreement with regional business units.
• Failure to follow and apply documented Quality Control could result in revenue loss associated with market actions including product recall.

KSA Requirements (Knowledge, Skills, and Abilities)

• Knowledge:  Working knowledge and application of ISO 13485 and 21 CFR 820.Subject matter expert of Quality Systems Regulatory requirements and  application to Company /Unit requirements
• Skills:  Excellent communication, problem solving, organizational and interpersonal skills are essential.
• Education/Degree:  BS Degree in Quality Engineering, Supply Chain or related Science discipline preferred or a combination of equivalent education and experience.
• Certifications (if applicable):  Industry Recognized certification in a Quality System Element specialty, (e.g ASQ Certified Quality Auditor, etc.) preferred.
• Experience (indicate the number of years):  A minimum of 3 years relevant experience or a combination of equivalent education and relevant experience in Medical Device and/or Pharmaceutical regulated industry within Quality, Supply Chain and/or Distribution Center operations. 
• For people management position, indicate years of experience required :  N/A
• Other:  Identify the minimal level of other competencies required for the position:  Computer skills (Excel, Word, Power Point, etc.) 
• Self-motivated and directed, requiring minimal supervision
• Demonstrated ability to work in teams to obtain results is required.
• Effective skills in analytical thinking and problem solving required

Primary Work Location

USA IN - Plainfield

Additional Locations

Work Shift