Quality Specialist

Quality Specialist at Medasource Quality Specialist at Medasource in Winthrop Harbor, Illinois Posted in about 23 hours ago.

Type:

full-time

Job Description:

Position Overview We are seeking four experienced Deviation Investigation Specialists (Investigative Writers) to support a high-volume deviation backlog at a GMP-regulated manufacturing site. These individuals will be responsible for authoring technical investigations, performing root cause analysis, and supporting CAPA activities within a regulated environment. Key Responsibilities Author technical deviation investigations using structured root cause analysis tools (5 Whys, 6M, etc.) Collaborate with cross-functional SMEs (Engineering, Manufacturing, Quality, TSMS) to gather investigation data Work directly within Veeva QMS (or similar) to document deviations and investigation outcomes Prepare and present Moderate and Major deviation summaries to the Deviation Review Board Initiate and support CAPAs in QMS Assist with CAPA implementation , including document updates, routing, and approvals (as needed) Must-Have Requirements Experience in a regulated industry (Pharma, Medical Device, Food, Cosmetics, etc.) Strong understanding of:

GMP / GDP 21 CFR

Parts 210 & 211 Deviation investigation writing experience Experience with Veeva QMS or similar QMS systems Proven experience with root cause analysis methodologies (5 Whys, Fishbone/6M, etc.) Preferred Qualifications Prior experience working in Veeva QMS environments Background in: Engineering (process/equipment deviations) Manufacturing or TSMS Quality Investigations Experience presenting findings to review boards or leadership Ideal Candidate Profile Strong technical writing and analytical skills Ability to work in a fast-paced, high-volume deviation environment Comfortable collaborating across multiple functions Self-sufficient and able to ramp quickly with minimal oversight