QA Engineer

Cordenpharma; Hygiene (CO); On-site; USD 90,000 - 108,000; Full time

Benefits offered by this job

401(k) matching

Critical Illness

Disability Insurance

Employee Assistance Program

Flexible Spending Account

Health Insurance PPO/HSA

Hospital Indemnity Plan

ID Theft

Life Insurance

Tuition Reimbursement

Wellness Program

Vision Insurance

Job summary

CordenPharma, a leading CDMO, seeks a QA lead to drive GMP-compliant quality activities in pharmaceutical development and manufacturing. The role focuses on engineering-related QA enhancements, with emphasis on protocols, reports, and product reviews.

Ideal candidates bring a four-year degree and 6+ years in pharma ops, strong documentation skills, and cross-functional collaboration abilities in a fast-paced environment.

Qualifications

• Four-year college program and 6 years’ experience in Pharmaceutical Development and/or Manufacturing Operations.
• Knowledge of GMP, ICH Guidelines, and other regulations.
• Excellent writing, interpretive, presentation, and interpersonal skills.

Responsibilities

• Supports QA department in engineering-related quality systems.
• Prepare or review and approve documents such as protocols and reports.
• Lead temperature mapping, water systems, utilities, and cleaning projects.
• Prepare Annual Product Reviews.

Skills

Quality Assurance

GMP knowledge

ICH Guidelines

Documentation

Equipment qualification

Analytical skills

Interdisciplinary collaboration

Education

Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, or related scientific field

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Regular Full-Time Boulder, CO, US

Salary Range: $90,000.00 To $108,000.00 Annually

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.

ESSENTIALDUTIESAND 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.

• Temperature Mapping
• Water System
• Utilities
• Cleaning
• Write protocols and reports
• Annual Product Reviews

LEADERSHIP & BUDGETRESPONSIBILITIES

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
• 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
• Critical Illness
• Disability Insurance
• Employee Assistance Program
• Flexible Spending Account
• Health Insurance PPO/HSA
• Hospital Indemnity Plan
• ID Theft
• Life Insurance
• Tuition Reimbursement
• Wellness Program
• 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