Sr CAPA Specialist – Quality Systems

Job Title: Sr CAPA Specialist – Quality Systems

Location: Minneapolis, MN 55432

Duration: 6 Months

HM's Top Needs:

1. CAPA Experience (ownership or CAPA specialist)
2. Organizational skills – manage a large # of tasks, keeps them progressing and completing on time.
3. Collaborative – able to work with owners to help them make the best documentation possible.

This person needs to be able to:

1. Handle the system administration of the Client’s CAPA Management System (Trackwise)
2. Organize and conduct CAPA Board meetings.
3. Ensure and aid CAPA owners in the creation of compliant CAPA documentation
4. Aid CAPA Owners by critically reviewing Investigation Plans, Root Causes, Action Plans, and Effectiveness Plans.
5. Aid CAPA board members by providing insights regarding the CAPAs and how the corrective actions will impact the production facility.
6. Ensure on-time progression of CAPA activities to the specified due dates.

Responsibilities may include the following and other duties may be assigned.

• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Coordinates legal requests in support of government investigations or litigations.
• Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

Required Knowledge and Experience:

Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.

May have practical knowledge of project management.

Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.