Quality System Specialist II (CAPA)
The Quality System Specialist II is responsible for the support of the quality system processes that have been established to identify, investigate, trend and correct and prevent customer complaints and product performance issues in the field.
The Specialist II works on projects of moderate scope, in which analysis of situations or data requires a review of identifiable factors.
Responsible for the reviewing and auditing of complaint and other quality records to assure compliance to internal SOPs, cGMP, ISO and other standards as applicable.
Serve as a resource for employees across all departments. Will follow up on issues pertaining to complaint handling, product quality, and will spend a significant amount of time directly interacting with staff across all departments.
Assist in generating monthly complaint metrics and report on complaint data as requested.
Support Customer Complaint Evaluation Board activities.
Provide support for complaint investigations, product performance investigations, process improvement initiatives and other quality system initiatives as requested by department management.
BA/BS or equivalent scientific experience (life science or engineering) required. Experience with electro-mechanical, and computer driven equipment desired. Candidate must have 3-5 years of working experience.
The Quality Specialist II should have a working knowledge of cGMP, QSRs, ISO standards, and other applicable regulations. The position also requires the ability to: audit records, procedures, data, and processes, effectively interact with all levels of personnel, multi-task and prioritize activities, and in general have the ability to be flexible.
Effective oral and written communication skills are mandatory. The candidate must be able to gather the appropriate data to make informed decisions.
About MSN Clinical Research:
Medical Staffing Network Clinical Research is the only recruiting and staffing firm you will want to work with. As one of the largest and most recognized national providers of healthcare staffing, MSN has the opportunities you want with the pay and benefits you deserve. Our expert Clinical Research division focuses on positions in clinical operations, data management, drug safety, biostatistics, medical writing, regulatory affairs and more. We offer contract, contract to hire, direct hire/executive search and large project-based staffing solutions, giving you access to a wide range of opportunities. With a strong focus on quality patient care, MSN has been Joint Commission Certified since 2005.
Posted 4 years ago