Specific Responsibilities:
- Performs raw material testing, as assigned.
- Reviews analytical data associated with raw material testing, including results from third party contract laboratories and method qualification / validation protocols, ensuring compliance to specifications / acceptance criteria, for testing not directly performed.
- Reviews raw material item specifications for testing requirements and sampling plans.
- Evaluates new raw materials for testing determination with compliance to master plan, compendia and ICH requirements.
- Provides Quality assessment for deviations, laboratory OOS investigations and change controls related to method and analytical instrumentation, for GMP and technical compliance, for testing not directly performed.
- Participates on project teams and collaborates throughout the project lifecycle ensuring analytical data compliance.
- Serves as contact for contract laboratories, QC and Analytical PD for raw material issues.
- Provides raw material data metrics.
- Revises and reviews master plans, SOPs, work instructions and training course plans for analytical instrument operation, raw material test methods, ensuring alignment with qualification documentation.
- Serves as SME during audits for raw material issues, as needed.
- Other duties as assigned.
Job Requirements
- BS/BA and 4+ years of raw material laboratory experience