What are the responsibilities and job description for the Quality Specialist position at Medasource?
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
Salary : $95 - $100