Please note the vacancies below will be removed after 30 days from the date the job was posted.

SAP QM Lead Consultant

Required skills job: Strong SAP skilled QM resource with experience doing an SAP Design. Familiar with functionality of QM (used to be hands on, but is more senior at this point). Life science experiences (a must) and can understand how this area is FDA Compliant and how QM fits within a life science environment. Has experience conducting client workshops, so communication,consulting,etc is also a must. The person will validate that the work already done is in compliance and identify gaps.Will then communicate this to the client.

More details on skill set:

Experience with QM in production, procurement and sales/distribution

Experienced in Quality Management, specifically:
Receiving, In-Process, Shipping, Customer Returns, Inspection characteristics and inspection plan setup and Quality Notifications
Experience in Quality Certificates for Customers and from Vendors
Shelf life control
Experience with hazardous material handling, including EH and S
Experience in a life sciences environment
Experience with CFR part 11
Experience with FDA compliance issues
Experience with electronic signatures, batch and serial tracking and reporting

Additional areas that might be identified during the workshops include:

Audit (especially with FDA)
Cycle times reporting
Open vs closed items
Root cause assessments
Trending Analysis
Customer complaint tracking:
Status reporting and email notifications
Trending by customer/part
Root cause
Training (employee certifications, compliance certifications etc)
Track required training-who,what,when
Email notifications
Schedule tracking
Certs coming due reporting
CAPA Reporting for:
Cycle time reporting
Disposition turnaround reporting
Reject analysis
Status reporting