Sr. QA Engineer

Job Description

Job Description

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.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
  1. Process flow diagraming/design of process
  2. Lean/Six Sigma
  3. Design of experiments
  4. Review of technical Quality guidance for implementation into site systems
  5. Measurement Systems and measurement systems analysis
  6. Calibration (gage repeatability & reproducibility) 
  7. Traceability to standards
• Application of statistical analysis tools for execution of job duties
  1. Concepts for probability and statistics, including drawing valid statistical conclusions
  2. Statistical process control/analysis and control charting
  3. Sampling plans development, including understanding the application of probability distributions
  4. 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
  1. Failure Mode and Effects Analysis (Process and others)
  2. Fault Tree Analysis
  3. 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 clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.

 

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

EDUCATION and/or EXPERIENCE

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. Ability to effectively present information to management and colleagues. 

 

MATHEMATICAL SKILLS

Competence in scientific mathematical skills and statistics, including metric analysis, trending, and reporting.

 

REASONING ABILITY

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

None.

 

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 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 regularly required to talk or hear. The employee frequently is required to stand and sit. The employee is occasionally required to walk; work with hands; reach above shoulder height; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus.

 

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. 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. The noise level in the work environment is usually moderate.

 

CORE COMPETENCIES

These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.

 

• Strong knowledge of current Good Manufacturing Practices, Quality Engineering principals, USP and ICH Guidelines, and other pertinent national and international regulations
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across different functions and levels of the organization
• Conflict resolution skills
• 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
• Proactive approach to problem-solving and resolution
• Detail-oriented approach to Quality Assurance
• Strong leadership capabilities with a proactive and solutions-oriented mindset
• Ability to thrive in a fast-paced and dynamic environment, managing multiple priorities effectively
• Commitment to continuous improvement and staying updated on industry trends and regulatory changes

 

SALARY

Actual pay will be based on your skills and experience.

BENEFITS

• 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service 
• Accident Plan
• Critical Illness Insurance
• Dental Insurance
• Disability Insurance
• Employee Assistance Program
• Flexible Spending Account
• Health Insurance PPO/HSA
• Hospital Indemnity Plan
• ID Theft Protection
• Life Insurance
• Paid Paretnal Leave
• Tuition Reimbursement
• Wellness Program
• Vacation – Three Weeks 1st Year
• Vision Insurance

EQUAL OPPORTUNITY EMPLOYER

Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.

This post will expire September 18, 2026