Quality Assurance (Entry Level)
Job Title: Quality Assurance (Entry Level) Location: Marlborough, MA Zip Code: 01752 Duration: 6 months Pay Rate: $ 45.36/hr. Keyword's: #Marlboroughjobs; #QualityAssurancejobs. Start Date: Immediate Job Description: Responsibilities:
- Lead a Complaint Handling Unit (CHU) supporting and executing the triage, investigation, and closure of product quality complaints. Tasks include coordinating and supporting investigations, running trend reports, performing statistical analysis of trends, tracking major issues and related corrective actions, assisting in final customer reports, and interfacing with customers in various forms of communications.
- Facilitate risk-assessment activities and acts as QA lead for Field Actions involving Aseptic Filling product groups
- Support internal and external audits as Subject Matter Expert from a complaint handling unit perspective
- Provide metrics and oversight of the deviation, CAPA, and complaint systems, including high-level analysis for management review
- Bachelor's degree in Biological Sciences, engineering, or related field (e.g., Biomedical Engineering, Systems Engineering, Pharmacology, Chemistry) or equivalent work experience
- Multiple years relevant experience dealing with post market surveillance activities (complaint triage, investigations, CAPA, etc.)
- Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English
- Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
- Experience with root cause analysis, nonconformance investigation, and CAPA management
- Experience in a regulated environment such as medical devices (ISO 13485), pharmaceuticals (GMP), or biotechnology.
- Proficiency with quality management systems (QMS) and tools like Veeva, TrackWise, Salesforce, Magic..
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