Sr. QA Engineer

Corden Pharma
Boulder, CO
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. We are seeking a Sr. QA Engineer to lead and manage Quality Assurance related projects and day-to-day Quality activities as needed.

Requirements

  • 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
  • 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
  • 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
  • Collaborate cross-functionally with all departments to ensure alignment on Quality standards and regulatory compliance
  • Provide guidance and support for Quality investigations
  • Mentor and train junior Quality engineers and other team members on Quality systems, regulations, and best practices

Benefits

  • 401(k) matching
  • 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 Parental Leave
  • Tuition Reimbursement
  • Wellness Program
  • Vision Insurance
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