Level 2 Systems Engineer managing technical support across multiple client environments in a fast - paced MSP. Collaborating with a small team while providing advanced troubleshooting and solutions.
About the role
- 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
Benefits
- Health insurance
- Professional development support
- Opportunities for growth in a global company
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