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Quality Systems Analyst
About the position
Taconic Biosciences is a leading provider of genetically engineered research models and services, specializing in genetically engineered mouse and rat models, microbiome research, and immuno-oncology models. Quality is the forefront of everything we do. We strive for excellence daily with the quality processes we have pioneered. We are currently seeking a process-focused Analyst responsible for maintaining and improving the Quality Management System (QMS) while driving continuous improvement through the organization. Role Summary This role ensures compliance with quality standards and regulatory requirements through effective quality assurance practices, document control, auditing, data analysis, and change management. Partners with cross-functional stakeholders to reduce process variation, mitigate risk, and improve operational performance using Lean Six Sigma methodologies. This is a hybrid-based role, that does require frequent visits to Taconic sites and suppliers.
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
- Ensure documentation accurately reflects current processes and approved practices.
- Coordinate and support internal, external, supplier, and regulatory audits.
- Facilitate process and site quality reviews. Maintain audit readiness.
- Track audit findings and support timely and effective responses.
- Support supplier quality activities, raw material approvals, and regulatory compliance programs (e.g. AAALAC, IACUC, AWB).
- Lead root cause investigations and implement corrective and preventative actions (CAPA).
- Apply Lean Six Sigma methodologies (e.g. DMAIC, root cause analysis, SPC) to reduce variation, eliminate waste, and prevent issue recurrence.
- Facilitate cross-functional change management activities to ensure effective planning, implementation, validation and sustainment of improvements.
- Track and report improvement initiatives through closure.
- Monitor process and system performance using Statistics Process Control (SPC) and other quality metrics.
- Analyze, trend, and report quality data to support data-driven decision making and risk identification.
- Maintain quality records, including deviations (internal and external).
- Support equipment calibration and validation documentation.
- Provide training on quality systems, quality processes, systems, and continuous improvement tools.
- Serve as a quality subject matter resource to internal stakeholders.
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, or technical/management experience at an equivalent level.
- 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
Nice-to-haves
- 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
Benefits
- A dynamic, mission-driven work environment focused on advancing human health.
- Dynamic and supportive team of individuals with a wide range of scientific training and professional experience.
- Competitive salary and performance-based incentives.
- We offer health insurance, and professional development support.
- Opportunities for growth in a global company at the intersection of science and industry.
