Job Description
Job Description:
Key Responsibilities
Lead planning and execution of CPV Stage 3A (Historical Transition Reports) and 3B (Annual Monitoring).
Coordinate data gathering from internal systems (TRU, ADPR, CEDMS, batch records) and external manufacturing partners.
Define data workflow: extraction
tabulation
verification
Minitab analysis
report compilation
routing for client approval.
Manage Jr and Sr Data Admins, ensuring strict separation between tabulation and verification functions.
Oversee statistical analysis outputs (Ppk, CPV limits, run charts, trend assessments) and ensure alignment with SOP0002200.
Ensure all data is tabulated, reviewed, and included in report appendices.
Identify discrepancies, trends, excursions, or shifts requiring escalation or SME evaluation.
Interface regularly with client QA, Tech Ops, Mathematical Sciences, and EM site partners.
Maintain timeline consistency across a 12month CPV cyc...
Key Responsibilities
Lead planning and execution of CPV Stage 3A (Historical Transition Reports) and 3B (Annual Monitoring).
Coordinate data gathering from internal systems (TRU, ADPR, CEDMS, batch records) and external manufacturing partners.
Define data workflow: extraction
tabulation
verification
Minitab analysis
report compilation
routing for client approval.
Manage Jr and Sr Data Admins, ensuring strict separation between tabulation and verification functions.
Oversee statistical analysis outputs (Ppk, CPV limits, run charts, trend assessments) and ensure alignment with SOP0002200.
Ensure all data is tabulated, reviewed, and included in report appendices.
Identify discrepancies, trends, excursions, or shifts requiring escalation or SME evaluation.
Interface regularly with client QA, Tech Ops, Mathematical Sciences, and EM site partners.
Maintain timeline consistency across a 12month CPV cyc...
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