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Sr. QA EngineerCordenpharma • Longmont, Colorado, United States
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Sr. QA Engineer

Cordenpharma
  • US
    Longmont, Colorado, United States
  • US
    Longmont, Colorado, United States
Jetzt Bewerben

Über

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.
Regular Full-Time Professional Boulder, CO, US
30+ days ago Requisition ID: 1763
Salary Range: $115,000.00 To $135,000.00 Annually
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
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
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), CPC manufactures in accordance with the U.S. 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
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
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
Critical Illness Insurance
Disability Insurance
Employee Assistance Program
Flexible Spending Account
Health Insurance PPO/HSA
Hospital Indemnity Plan
ID Theft Protection
Life Insurance
Paid Parental Leave
Tuition Reimbursement
Wellness Program
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.
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  • Longmont, Colorado, United States

Sprachkenntnisse

  • English
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