Quality Assurance Associate

VERO BIOTECH INC•Atlanta, GA

28d

About The Position

Why Join VERO Biotech? Our Mission: At VERO Biotech, our mission is to improve the lives of patients by developing innovative technologies that support critical care and respiratory therapy through inhaled nitric oxide delivery in the acute care hospital setting or wherever nitric oxide treatment is needed. We strive to exceed customer expectations in terms of safety, efficacy, and value by focusing on the science, development, and commercialization of our innovations. Position Summary Responsible for ensuring that the quality of products being manufactured meet the prescribed quality levels. Performs Quality Assurance activities, including review of manufacturing and final product release activities. Performs Quality oversight/observations for in-process verification/inspection activities within manufacturing areas, such as reworks.

Requirements

At least 2 years, minimum, as a Quality Assurance Associate (or equivalent experience)
College degree required, preferably in a scientific discipline.
2+ years’ experience in FDA/cGMP regulated environment. FDA 21CFR210/211/820 and ISO14845.
Strong communication skills with keen attention to detail.
Must have strong organization skills with attention to detail and accuracy.
Proficiency in the use of MS Word, Excel and Outlook. MS Access and other software tools, a plus.
Must have good basic mathematical skills
Excellent verbal and written communication skills in English

Responsibilities

Monitors/reviews the quality system including records and results from processes and procedures to ensure product Quality and compliance for any/all products (i.e. cassettes/consoles).
Ensures documentation is accurate, maintained, and reflects GMP, procedural and regulatory requirements.
Reviews Quality Controls records and certificates to ensure accuracy and acceptability of analytical results
Maintains knowledge of current regulatory requirements pertaining to drug/device manufacturing.
Performs label control functions
Participates in investigations of quality issues as required.
Supports Quality functions for batch record and label issuance, personnel and material flow, and batch release.
Performs QA release of final products in accordance with procedures
Reviews Standard Operating Procedures (SOPs) for manufacturing processes (may assist with revisions as needed).
Participates in continuous improvement objectives to assure compliance with regulations.
Develops and/or maintains metrics and trending reports for compliance related activities.
Supports internal audits and regulatory inspections.
Leads and mentors Quality personnel, including promoting quality culture and supporting quality objectives.
Performs QA receiving, issuance inventory
Performs Quality observations and in-process inspection/verification activities, such as reworks, on the production floor to provide Quality oversight (as assigned by Management)
Reviews applicable logbooks
Other related duties as assigned.