Senior QA Engineering

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.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.
Is a subject matter expert in multiple Quality Engineering disciplines. Leads and manages Quality Assurance related projects and day-to-day Quality activities as needed. 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. Lead multiple projects for the execution of areas of Quality Engineering oversight for Facilities, Utilities, Maintenance and Engineering

• Lead and manage Quality Assurance/Engineering projects related to pharmaceutical manufacturing processes; including, but not limited to, process validation, equipment qualification, and change control
• Experience with Purified Water Systems
• Execute Quality concepts on delegated areas
• Lean/Six Sigma
• Review of technical Quality guidance for implementation into site systems
• Measurement Systems and measurement systems analysis
• Application of statistical analysis tools for execution of job duties
• Concepts for probability and statistics, including drawing valid statistical conclusions
• Statistical process control/analysis and control charting
• Sampling plans development, including understanding the application of probability distributions
• Testing for comparison of populations/proportions (means/variances)
• Educate and advise personnel on Quality Engineering principles and tools, including implementation of tools and their use in analysis of Quality systems and GMP data
• Develop and implement Quality systems and procedures to ensure compliance with FDA, GMP, and other regulatory requirements
• Conduct risk assessments and root cause analyses for deviations, non-conformances, and CAPA (Corrective and Preventive Action) plans. Failure Mode and Effects Analysis (Process and others)
• Fault Tree Analysis
• Collaborate cross-functionally with all departments to ensure alignment on Quality standards and regulatory compliance

Provide guidance and support for Quality investigations, ensuring thorough documentation and timely resolution of issues
Mentor and train junior Quality engineers and other team members on Quality systems, regulations, and best practices
Safety & Environmental Responsibilities
Every individual is personally responsible for the safety and environmental aspects of their activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

QUALITY RESPONSIBILITIES

Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC's Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Four-year college or university program certificate in Chemical Engineering, Chemistry, Biochemistry, or related scientific field and 15 years' experience in Pharmaceutical Development and/or Manufacturing Operations.
Language Skills
Ability to read, analyze, and interpret common scientific and technical journals, regulatory, and compliance documents. Competence in scientific mathematical skills and statistics, including metric analysis, trending, and reporting.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables.
Certificates, Licenses, Registrations
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to wet and/or humid conditions, moving mechanical parts, and outside weather conditions. These are the specific areas of knowledge, skill and ability that are important for successful job performance. Strong knowledge of current Good Manufacturing Practices, Quality Engineering principals, USP and ICH Guidelines, and other pertinent national and international regulations
Good knowledge of Good Engineering Practices and pharmaceutical manufacturing
Strong analytical skills with the ability to conduct root cause analysis and implement effective CAPA actions
Detail-oriented approach to Quality Assurance
Commitment to continuous improvement and staying updated on industry trends and regulatory changes