QMS Investigator I
Core
Investigate, author, and coordinate deviations, corrective and preventative actions, complaints, and cGMP documents to support manufacturing operations and resolve issues.
Role type
Entry-level Quality Management System (QMS) Investigator
Builds
Deviation reports, CAPA documentation, and batch record revisions
Domain
Biopharma / Manufacturing / Quality Assurance
Required skills
cGMP/GLP compliance, technical documentation authoring, data tracking and trending, SOP adherence, Microsoft Office proficiency
Preferred skills
Life Sciences degree, CGMP manufacturing experience, investigation experience, English writing skills
Responsibilities
Initiate and support investigation completion for operations/production issues, author and revise deviations and complaints, manage components of large-scale deviations, track and trend documentation data, follow up on open records for timely close-out, support internal and regulatory audits
Seniority
Entry-level, individual contributor
