Sr. Quality Assurance Specialist

National salary range: $70,000 - $115,000. California range: $70,304 - $115,000; Washington range: $80,169 - $115,000.

About the role

Support the planning and coordination of all aspects of quality assurance activities with various levels of risk and complexity within a variety of scopes at the site or multi-site level. Act as the primary quality assurance customer contact for the site and the subject-matter expert on selected governmental regulations. Supervise the maintenance and continuous improvement of the overall quality system, including management review, CAPA management, internal quality audits, quality self-assessments, change control, document control, and standard operating procedures/work instructions.

Responsibilities

• Coordinate requests for quality support from the site and communicate policies and procedures.
• Coordinate select licenses, permits, and registrations.
• Analyze information and product specifications to determine regulatory compliance for products handled and services performed at the site.
• Lead select key regulatory, customer, and third-party audits.
• Monitor the training and development of site associates to ensure compliance with processes and regulations.
• Manage Quality Technicians within the site, as applicable.
• Track and maintain quality assurance metrics for the organization.
• Act as a customer contact for QA-related issues and initiatives as needed.
• Partner with QA management to develop, distribute, and maintain regular management reports.
• Read, interpret, and communicate technical documents and regulations.
• Maintain the site CAPA system for handling complaints and non-conformances.
• Write and maintain work instructions, SOPs, and customer-specific processes; ensure the team is trained on applications.
• Maintain document and change control for all regulated documents.

Requirements

• Bachelor’s degree or equivalent four years of work experience.
• Certification related to quality control (preferred).
• 2+ years of experience in a regulated environment or ISO 9001 compliant/certified.
• Experience in manufacturing, food, life sciences, or 3PL industry.
• Working knowledge of regulations such as FDA, GxPs, ATF, DEA, etc.
• Experience supervising or implementing quality control.
• Experience as an administrator of training in compliance with regulated standards.
• People management experience.

Skills

• Sufficient computer application experience.
• Strong written and verbal communication.
• Data analysis.
• Training and facilitation.
• Self-management.
• Problem-solving.
• Project management.
• Presenting and report creation.

Benefits

• Medical, dental, and vision coverage.
• Prescription benefits.
• Discounted stock purchase plan.
• General bonus plan.
• Generous PTO policy.