In-Process Quality Engineer II

Job Description

Title: In-Process Quality Engineer II

Job Summary

A leading pharmaceutical company is seeking to expand their Quality Engineering team! The Quality Engineer performs a variety of quality-related functions with the intent of providing Quality guidance and support to manufacturing operations at the St. Louis Plant. The scope of the position includes responsibility in OOS investigations, CAPAs, Exceptions, Change Controls, and Customer Complaints. Serves a technical resource in the Quality function in partnering with Manufacturing, Supply Chain, and other Quality groups.

As a Quality Engineer II, you will:

Review and approve Exception and OOS investigations, CAPA's, Change Controls, and Customer Complains in TrackWise system

Organize and document Material Review Boards for product disposition

Provide direct support for regulatory inspections and customer audits

Review release packets prior to final release of Finished Goods

Participate in Root Cause Analysis and Process Improvement teams

As a Quality Engineer II, you need to have:

BS in Chemistry, Chemical Engineering, related science or similar education

At least 3 years of experience in QA in a pharmaceutical manufacturing environment

Experience with quality metrics, manufacturing investigations and product release

As a Quality Engineer II, you should have:

Knowledge of cGMPs and APIs including ICH Q7, CFR 210 and 211

Manufacturing or QC experience

Knowledge of Quality Systems

Excellent verbal and written communication skills

Must be authorized to work in the US without sponsorship

Ability to build and lead effective teams

Salary:

$80,000 - $85,000Company Description

A top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.

Job Responsibilities:

•\tConducting Post Market Activities and Post Market Surveillance

•\tManaging Customer and Product Complaint Investigation programs

Education and Experience:

•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry

•\tBachelor's degree

•\tComputer proficiency

Full-time