Senior Quality Specialist

Job Title: Senior Quality Specialist

Location: On Site - Lafayette, Colorado, United States

About The Opportunity:

Join a growing organization within a regulated industry that is focused on delivering high-quality, reliable solutions. This is an opportunity to play a key role in supporting quality management systems, regulatory compliance, documentation practices, and continuous process improvement. As a Senior Quality Specialist, you will collaborate across departments to help maintain compliance with applicable standards and regulatory requirements while supporting quality processes across the organization.

Responsibilities:

• Support quality records and related documentation, including customer interactions, deviations, investigations, and other internal or external quality events.
• Drive documentation for deviations, nonconformances, CAPAs, and related quality activities with cross-functional partners.
• Ensure complaints and quality issues are investigated promptly, documented accurately, and closed in accordance with established procedures.
• Support and manage training records, competency documentation, and continuing education requirements, ensuring completion timelines are met.
• Track and report quality-related timelines, testing activities, training completion, or other compliance-related metrics across the organization.
• Collaborate with Subject Matter Experts, internal teams, and external parties to gather additional information for complaints, investigations, and customer interactions as needed.
• Assist in generating and presenting quality system metrics at quality review meetings and cross-functional business reviews.
• Support external and internal audit activities, including tracking and resolving audit findings, observations, nonconformances, and opportunities for improvement.
• Create and update standard operating procedures, work instructions, forms, and other controlled documents relevant to quality processes.
• Drive quality improvement initiatives across departments and provide education and assistance on quality processes to the organization.
• Support review and delivery of quality-related data, documentation, or project information for internal and external stakeholders.
• Escalate quality or compliance concerns that may require additional review, reporting, or corrective action.

Must-Have Skills:

• Minimum of 2 years' professional experience in document control, training, quality assurance, compliance, or a related function within a regulated industry.
• Hands-on knowledge of quality management systems, ISO standards, FDA regulations, or other applicable regulatory requirements.
• Strong skills in quality assurance, controlled documentation, SOP management, and supporting regulated manufacturing, laboratory, or operational environments.
• Excellent organizational and time management abilities, with a demonstrated capacity to prioritize tasks and manage multiple projects.
• Competency in Microsoft Office applications, including SharePoint, Teams, Word, Excel, and PowerPoint.
• Knowledge of best practices for handling confidential, sensitive, or regulated information.
• Effective communicator able to collaborate across teams, departments, and external parties.

Nice-to-Have Skills:

• Undergraduate degree in a relevant field.
• Experience supporting audits and presenting quality metrics to cross-departmental teams or quality review boards.
• Familiarity with regulated reporting processes or escalation requirements.
• Continuous improvement mindset with experience optimizing quality system workflows.
• Ability to analyze quality issues, make informed decisions, and resolve conflicts efficiently.
• Background supporting quality activities within biotechnology, life sciences, medical device, diagnostics, pharmaceutical, manufacturing, or another regulated environment.