Pharma QA Engineer – GMP, Validation & Compliance

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

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.