Specialist Manufacturing
Core
Support manufacturing/quality systems including non-conformances, process validation, procedures, training, and new product introductions in a pharmaceutical/biotech environment.
Role type
Specialist Manufacturing (Process Support & Quality Systems)
Builds
Manufacturing processes and quality systems for pharmaceutical, biotechnology, medical devices, and food industries
Domain
Life Sciences / Bioprocessing / GMP Manufacturing
Required skills
GMP production operations, Root Cause Analysis, Lean Manufacturing, process monitoring, regulatory compliance, technical writing, project management, control charting
Preferred skills
Bio-processing unit operations, Trackwise, VEEVA, MES, Power BI, Spotfire, CDOCS, English/Spanish bilingualism
Technologies
Trackwise, VEEVA, MES, Smart Sheet, Power BI, Spotfire, CDOCS
Responsibilities
Initiate and approve manufacturing procedures, assess process performance via observation and data review, support process validation protocols and execution, manage non-conformance triage and CAPA closure, participate in regulatory inspections, support new product introductions and equipment modifications, assist with change control packages
Seniority
Mid-level, individual contributor
