Sr. QA Engineer

Corden Pharma 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

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. Represents the highest level of GMP understanding and accomplishment.

ESSENTIAL DUTIES AND 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.

* 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

* Functional knowledge of control systems, their infrastructure, and qualification

* Knowledgeable in cleanroom requirements as it applies to Annex 1

* Experience with Purified Water Systems

* Experience with Spray Dryers, Lyopilizer, and TFF Skids

* Execute Quality concepts on delegated areas

* Process flow diagraming/design of process

* Lean/Six Sigma

* Design of experiments

* Review of technical Quality guidance for implementation into site systems

* Measurement Systems and measurement systems analysis

* Calibration (gage repeatability & reproducibility)

* Traceability to standards

* 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. This includes deep knowledge in

* Failure Mode and Effects Analysis (Process and others)

* Fault Tree Analysis

* Design review in comparison to system specifications (user, functional, and detailed design specifications)

* 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

LEADERSHIP & BUDGET RESPONSIBILITIES

Provide guidance and leadership where appropriate.

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. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.

cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to…