ea jobs (salary & requirements)

【Summary of Responsibilities:】
•Manages CAPAs to resolution.
•Provides monthly report of activities to Sr. QA Manager/QA portfolio Manager.
•Oversees timely completion of CAPAs QIs in QMS.
•Supports internal external teams in creation of CAPAs.
•Maintains good working knowledge of GCP knowledge of regulatory authority requirements inspection support.
•Interacts with QA Lead Sr. Manager above as required fquality issue case progression, issue escalations client notifications.
•Supports QA lead Sr. Manager above in pulling metric data, trending, tracking of QIs fclient metrics.
•Hosting of external audits/inspections e.g., regulatory inspections, strategic clients.
•Ensure Regulatory Compliance Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed.
•all other duties as needed assigned
【Qualifications (Minimum Required):】
•A minimum of a bachelor’s degree in Life Sciences preferred (equivalent Life Science experience)
•Experience may be substituted feducation.
【Experience (Minimum Required):】
•5 years in regulatory environment (experience in GXP roles)
•Strong understanding of QMS CAPA processes.
•Ability to manage client responsibilities.
•Report communicates key quality information to Sr. Managers QA
•Able to work effectively within a team environment.
•Able to communicate effectively during client meetings.
•Knowledge of GCPs/GxPs.