QA Engineer

Corden Pharma - A Full-Service CDMO; Boulder (CO); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

401(k) matching

Accident Plan

Dental Insurance

Disability Insurance

Health Insurance PPO/HSA

Paid Parental Leave

Tuition Reimbursement

Wellness Program

Vacation – Three Weeks 1st Year

Job summary

CordenPharma is a leading full-service CDMO focused on APIs, excipients, drug products, and packaging. This role supports the Quality Assurance function, promoting GMP compliance and high-quality documentation across projects to ensure patient safety and product quality.

We seek a candidate with a four-year degree in a related field and 6 years of pharmaceutical experience, strong writing abilities, and a proactive problem-solving mindset.

Qualifications

• Requires a four-year college degree in Chemistry, Chemical Engineering, Biochemistry, or related field.
• Minimum 6 years of experience in pharmaceutical development and/or manufacturing operations.
• Knowledge of GMP, ICH Guidelines, and regulatory requirements.
• Excellent writing and interpersonal skills.
• Ability to work with cross-functional teams.

Responsibilities

• Support QA in quality systems and document management across projects and activities.
• Prepare, review, and approve protocols and reports.
• Assist with equipment qualification, validation, and qualification documentation.
• Contribute to annual product reviews and related activities.
• Support risk assessments, environmental monitoring, and related quality systems.

Skills

GMP knowledge

Documentation skills

Analytical skills

Cross-functional teamwork

Education

Bachelor's degree in Chemistry or related field

Job description

CordenPharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical, and biotech companies manufacture medicines with the ultimate goal of improving people’s lives.

Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.

Our People Vision

We strive for excellence. We share our passion. Together, we make a difference in patients' lives.

Summary

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.

Essential Duties And Responsibilities

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 assigned.

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

LEADERSHIP & BUDGET RESPONSIBILITIES

Provide guidance and leadership where appropriate.

EDUCATION And/or EXPERIENCE

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.

CORE COMPETENCIES

These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.

• 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

SALARY

Actual pay will be based on your skills and experience.

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

EQUAL OPPORTUNITY EMPLOYER

Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.

This post will expire September 18, 2026