Sr Quality Assurance; QA Specialist

Overview

IDT is a Danaher operating company. The Sr Quality Assurance (QA) Specialist is responsible for providing administration, coordination, and maintaining the key components of the Quality Management System at the Boulder, CO site. This may include but is not limited to document control, nonconformances, deviations, training and other process control functions. This position reports to the Sr Manager, Quality Systems and is part of the Quality and Regulatory Affairs group located in Boulder Colorado and will be an on-site role.

Why IDT (a Danaher operating company) is built on collaboration, scientific excellence, and continuous improvement to accelerate genomics breakthroughs and improve lives.

• Ensure the timely completion and investigation into Quality event investigations (Nonconformances, Deviations, and support of Customer Complaints).
• Complete timely review and release of batch records, inspections, and COA creation for various raw materials, in-process materials, subassemblies, and finished goods in accordance with product specifications.
• Interact professionally and efficiently cross functionally with Manufacturing and various support teams;
  Logistics, R&D, Product Management, Supply Chain Planning, and QC.
• Implement, maintain, and improve IDT’s Quality Management System in accordance with ISO 13485, 21 CFR 820 and regulatory guidance documents. Works with the IDT Global QS team.
• Participate in internal and external audits, as needed.

• Bachelors degree in life sciences preferably in biology, chemistry, biochemistry or related field
• 3+ years of Quality Assurance experience in a manufacturing industry, biotechnology and next-generation sequencing preferred
• 3+ years of experience working in medical devices preferred
• Experience with quality management systems and regulatory standards such as ISO:9000, ISO:13485, FDA QSR, or cGMP is preferred. Demonstrated familiarity with one or more of these frameworks in a regulated environment.
• Proficiency with computers and a variety of software (e.g., Microsoft Office Suite)

• Strong verbal, written, analytical, and persuasive skills with the ability to interact effectively with all levels of employees and management.
• Ability to take responsibility for directing, controlling, or planning a project.
• Experience with SAP, Master Control, and Maintenance Connection.

IDT offers a comprehensive benefits package including health care, paid time off, and a 401(k). Salary range for this role is $85,000 - $100,000 and is eligible for bonus/incentive pay. This range is the company’s good faith belief at posting and may be modified.

Danaher and IDT are equal opportunity employers. We comply with federal and state disability laws and provide reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, please contact or

Contact Name: IDT (Integrated DNA Technologies)

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