Quality Specialist, Systems
Quality Specialist, Systems
Quality Assurance / Systems
Direct Reports (list)
Reports to (title)
To be completed by Corporate Compensation:
Job Summary - a concise overview of the job
The Quality Specialist, Systems will serve as the lead on the shop floor managing investigations/deviations and the review of documentation i.e. raw material release, bulk release, LIMs sample review. Monitors, tracks, and trends Right the First Time (RFT), Non-Conformances, CAPA, and other Quality Systems. Provides metrics to the Quality Systems and Technology Department for the corporate Quality Index. Works with the team in maintaining a collaborative environment.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Will partner with the Quality (shop floor and disposition), Manufacturing, Packaging, Engineering and Technical Operations groups for investigation review and metrics generation.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
Monitors, tracks, and trends NCR, CAPA, RFT, etc.
Monitors and tracks RFT and reviews/approves raw material release, bulk release, LIMs sample review, etc.
Initiates communication of due dates for Quality Systems (NCRs, CAPA, Complaints, etc.) to ensure they are completed on time
Assist in the preparation of Materials for Annual Product Reviews
Assists in the preparation of materials for Quality Council and Management Review
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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Endo Job Description Template - Revised July 2012