QA Engineer

Corden Pharma Colorado• Boulder, CO, US, CO

12h•$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. Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

Requirements

Four-year college or university program certificate in Chemical Engineering, Chemistry, Biochemistry, or related scientific field and 6 years’ experience in Pharmaceutical Development and/or Manufacturing Operations.
Ability to read, analyze, and interpret common scientific and technical journals, regulatory and compliance documents.
Ability to effectively present information to management and colleagues.
Competence in scientific mathematical skills and statistics, including metric analysis, trending, and reporting.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables.
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