Sr. QA Engineer

About the role

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.

Responsibilities

• Supports the Quality Assurance Department in the following functions/projects.
• Improves the efficiency and effectiveness of all engineering related Quality systems.
• Generates or reviews and approves 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.
• 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.
• Ledan/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).
• Education 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.

Qualifications

• 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.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.

Core Competencies

• 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.