Senior QA Engineer — GMP & Equipment Validation

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 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.