What are the responsibilities and job description for the Quality Control Method Validation position at Intellectt Inc?
Job Title: Quality Control Method Validation Scientist in Denver, Colorado
Job Summary
We are seeking an experienced Quality Control Method Validation Scientist to support the development, transfer, validation, and verification of analytical methods within a regulated QC laboratory environment. This role will also be responsible for validating analytical instruments and ensuring compliance with global regulatory and GMP requirements.
Key Responsibilities
- Develop, execute, and document method transfer, validation, and verification protocols for QC analytical methods, including:
- Container Closure Integrity Testing (CCIT)
- Particulate Matter testing (USP <788>)
- Antimicrobial Effectiveness Testing (USP <51>)
- Author and maintain analytical method SOPs across multiple product codes.
- Perform method troubleshooting and root-cause investigations.
- Lead validation activities for QC analytical instruments (e.g., spectrometers), including:
- Reviewing and updating User Requirements Specifications (URS)
- Developing system design, configuration, and qualification documentation
- Reviewing and maintaining instrument operation and maintenance SOPs
- Supporting vendor-led Installation and Operational Qualification (IOQ)
- Developing and executing Performance Qualification (PQ) protocols
- Authoring PQ final reports, including traceability matrices and data integrity assessments
- Ensure compliance with cGMP, data integrity, and regulatory expectations.
- Collaborate with cross-functional teams including Quality, Engineering, and Vendors.
Qualifications
- Bachelor’s degree or higher in Chemistry, Biology, or a related scientific discipline.
- Minimum of 5 years of experience in manufacturing, quality, or engineering within the biotech or pharmaceutical industry.
- Strong experience in method development, qualification, and validation.
- In-depth knowledge of ICH Q2, USP, EP, and JP pharmacopeial requirements.
- Hands-on experience with analytical instrumentation preferred.
- Solid understanding of chemistry fundamentals, laboratory safety, and best laboratory practices.
- Working knowledge of cGMP requirements for Quality Control laboratories.