QA Engineer

Corden Pharma Colorado• Boulder, CO, US, CO

2d•$90,000 - $108,000•Onsite

About The Position

Leads and assists in Quality Assurance related projects and day-to-day quality activities as needed. Represents the highest level of GMP understanding and accomplishment. Supports the Quality Assurance Department in the following functions/projects. Responsible for improving the efficiency and effectiveness of all engineering related quality systems. Will have responsibility for generating or reviewing and approving the following document types. Other duties may be mentioned. Provides guidance and leadership where appropriate.

Requirements

Knowledge of current Good Manufacturing Practices, ICH Guidelines, and other pertinent national and international regulations
Excellent writing, interpretive, presentation, and interpersonal skills
Conflict resolution skills
Understanding of equipment qualification and validation
Good knowledge of good engineering practices and pharmaceutical manufacturing
Analytical skills with the ability to function with interdisciplinary teams
Proactive approach to problem solving and resolution

Responsibilities

Equipment Qualification documents
Temperature Mapping
Water System
Utilities
Environmental Monitoring
Risk Assessments
Cleaning
Write protocols and reports
Annual Product Reviews

Benefits

401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
Accident Plan
Critical Illness
Dental Insurance
Disability Insurance
Employee Assistance Program
Flexible Spending Account
Health Insurance PPO/HSA
Hospital Indemnity Plan
ID Theft
Life Insurance
Paid Parental Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance