Job Description Responsibilities of the Raw Material CTL Lead include:
- Represent as the Single Point of Contact for all raw material test labs
- Facilitate and effectively communicate information between the company and external test partners
- Lead resolution of CTL (Contract Test Laboratories) operational issues that impact the company and collaborate with other 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
- Masters Degree, contract testing experience and 3+ years of experience in GMP or similar OR
- Bachelors Degree, contract testing experience and 5+ years of experience in GMP or similar OR
- Associates 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 Pay ranges between 45-55/hr based on experience