Incoming QA Specialist
Core
Ensuring quality compliance for incoming raw materials, single-use assemblies, and bulk drug substances in a biologics manufacturing environment.
Role type
Incoming QA Compliance Specialist
Builds
Incoming quality assurance release of materials for drug product manufacture
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, regulatory requirements knowledge, quality oversight, investigation leading, specification authoring, SOP development, stability program support, quality log administration, continuous improvement
Preferred skills
None stated
Technologies
None stated
Responsibilities
Complete incoming quality assurance (IQA) release of raw materials, single use assemblies and bulk drug substance; Provide quality oversight of sampling requirements for excipients; Lead or assist in investigations arising from specifications results; Review and audit completed release records; Author specifications and standard operating procedures; Act as SME during regulatory and internal inspections; Complete quality review of operations documentation; Provide Stability Program Support including sample pulls and protocol generation; Maintain finished product status and labeling; Administer Quality Logs.
Seniority
Mid-level, hands-on IC