Sr. Quality Assurance Specialist

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

Benefits

• Medical, Dental, and Vision coverage
• Prescription drug plan
• Discounted Stock Purchase program
• General Bonus Plan
• Generous PTO policy

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 regarding selected governmental regulations.

Responsibilities

• Respond to requests for quality support from the site and communicate policies and procedures
• 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
• Coordinate select licenses, permits, and registrations
• Analyze information and product specifications to determine regulatory compliance with regards to 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/initiatives as needed
• Partner with QA management to develop, distribute, and maintain regular management reports
• Read, interpret, and communicate technical documents and regulations
• Maintain site CAPA system for handling complaints and non-conformances
• Write and maintain work instructions, SOPs, and customer-specific processes, and ensure the team is trained on applications
• Maintain document and change control with all regulated documents

Requirements

• Bachelor’s Degree or equivalent 4 years of work experience
• Certification related to quality control (preferred)
• 2+ years of experience in a regulated environment or ISO 9001 compliant/certified
• Manufacturing, Food, Life Sciences, or 3PL Industry experience
• 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
• Sufficient computer application experience

Skills

• Strong written and verbal communication
• Data analysis
• Training and facilitation
• Self-management
• Problem-solving
• Project management
• Presenting and report creation