Quality Systems Analyst ensuring compliance with quality standards and regulatory requirements. Driving continuous improvement in a global biosciences company.
Responsibilities
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
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