Raw Material CTL Lead

Description:

Internal Title: Raw Material CTL Lead

Location: Remote

Schedule: M-F 8:00-17:00 PST

Contract/CTH: 8 month contract only

Job Description

Responsibilities of the Raw Material CTL Lead include:

• Represent client as the Single Point of Contact for all raw material test labs
• Facilitate and effectively communicate information between client and external test partners
• Lead resolution of CTL (Contract Test Laboratories) operational issues that impact client and collaborate with other client functions to resolve other quality or technical issues
• Track and communicate raw material sample testing status and delays to internal stakeholders and leadership teams
• Obtain CoA release dates from contract test labs and weekly reports, and update internal trackers
• Triage SCARs (and deviations and CAPAs as needed) related to raw material test labs and notify stakeholders
• Create and distribute monthly raw material testing forecast to CTLs
• Track accuracy of raw material test forecast and work with data analytics to resolve discrepancies
• Update forecast data sheet monthly with updated and new raw material specifications
• Approves CTL invoices and manages PO spend for each test lab
• Be the first point of contact for CTL invoice resolution and ensure resolution of CTL invoice inquiries
• Lead intake for new scopes of work for raw material test labs: Gather requirements from end users, request quotes from CTLs, initiate sourcing request for SOWs, and create and own GMP POs
• Gather operational metrics and content for business review meeting with CTLs
• Support ES&P QMR with raw material test lab metrics (as requested)

Education Level

• Master's Degree, contract testing experience and 3+ years of experience in GMP or similar OR
• Bachelor's Degree, contract testing experience and 5+ years of experience in GMP or similar OR
• Associate's Degree, contract testing experience and 7+ years of experience in GMP or similar
• High School Degree, contract testing experience and 10+ years of experience in GMP or similar

Experience

• Demonstrates knowledge of Good Manufacturing Practices (GMPs)
• Demonstrates experience working with contract test laboratories or other external contract organizations
• Demonstrates working knowledge of collaboration within a matrix environment
• Demonstrates diplomacy skills and ability to proactively identify and mitigate risks
• Demonstrates outstanding organizational skills with the ability to multi-task and prioritize
• Demonstrates strong analytical and problem-solving skills and strong data analytics skills e.g. Tableau, Excel
• Demonstrates excellent oral and written communication skills
• Demonstrates discipline in planning and plan execution
• Quick learner of new technology/process/work environment and ability to translate learning to work plans for improving business performance
• Patient centric mindset
• Superior work ethic and a strong personal desire for success