
Quality Systems Analyst
Taconic Biosciences
full-time
Posted on:
Location Type: Hybrid
Location: Germantown • New York • United States
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Salary
💰 $70,000 - $75,000 per year
About the role
- Maintain and continuously improve the QMS to ensure ongoing compliance with internal standards and applicable regulatory requirements.
- Facilitate the development and revision of Standard Operating Procedures (SOPs), work instructions, validation documents, and quality records.
- Administer the electronic document control system, including change control, version management, and archival.
- Coordinate and support internal, external, supplier, and regulatory audits.
- Facilitate process and site quality reviews.
- Lead root cause investigations and implement corrective and preventative actions (CAPA).
- Monitor process and system performance using Statistics Process Control (SPC) and other quality metrics.
- Provide training on quality systems, quality processes, systems, and continuous improvement tools.
Requirements
- Bachelor’s degree or equivalent experience in a professional, technical, or scientific field
- Quality Assurance or Science-Technology-Engineering-Mathematics (STEM), or a related field preferred
- Certifications from American Society for Quality (e.g. CQA, EQE) and/or Lean Six Sigma (green belt) preferred
- Knowledge of statistical process control (SPC), measurement systems analysis (MSA) and design of experiment (DOE) are strongly preferred
- A good communicator that is efficient at forming relationships with various members of the business and customers
- Live within driving distance of our US based sites, preferably Germantown, NY or Albany, NY
- Can prioritize based on varying business needs and demands, sometimes quickly
Benefits
- Health insurance
- Professional development support
- Opportunities for growth in a global company
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality Management System (QMS)Standard Operating Procedures (SOPs)Change ControlVersion ManagementCorrective and Preventative Actions (CAPA)Statistical Process Control (SPC)Measurement Systems Analysis (MSA)Design of Experiment (DOE)Continuous Improvement Tools
Soft Skills
CommunicationRelationship BuildingPrioritizationEfficiency
Certifications
Certified Quality Auditor (CQA)Engineer in Training (EIT)Lean Six Sigma Green Belt