Quality Assurance Specialist III

Partner Therapeutics • Lynnwood, WA

452d • $95,000 - $117,500

About The Position

The Quality Assurance Specialist III at Partner Therapeutics plays a crucial role in ensuring compliance and quality standards within the manufacturing operations. This position involves leading investigations, managing CAPA processes, and providing oversight for GMP activities. The specialist collaborates with cross-functional teams to enhance quality systems and processes, ensuring that all operations meet regulatory requirements and industry standards.

Requirements

• Skilled with electronic Quality Systems (e.g. Track Wise, MasterControl preferred).
• Familiarity with Root Cause Analysis tools (e.g. 5 why's, comparative analysis, Ishikawa).
• Strong critical thinking, analytical, and problem-solving skills.
• Resourceful with proven ability to lead and manage an internal network of stakeholders.
• Strong collaborative relationship management and interpersonal skills.
• Excellent organizational and prioritization skills.
• Strong written and oral English communication skills.
• Proven ability to make clear and persuasive presentations.

Nice To Haves

• Familiarity with risk-based thinking or risk-based tools.
• Experience in project management or formal training.
• Software expertise in Excel, PowerPoint, and SharePoint.

Responsibilities

• Lead deviation evaluation meetings and determine if escalation to CAPA is appropriate.
• Participate in Root Cause Analysis and development of CAPA plans.
• Complete review and approval of compliance documents including SOPs, Deviations, Validation Documents, and Quality records.
• Support site projects for continuous improvement to achieve project outcomes on time.
• Participate in QA on the floor activities to ensure successful partnering with functional areas.
• Build skills to interpret complex documentation for compliance procedures and FDA enforcement action/trends.
• Act as the point of contact for specific quality issues and provide feedback during walk-throughs.
• Support the development and maintenance of Quality Standards and Policies.
• Participate in regulatory inspections and resolve issues by ensuring timely escalation to Leadership.
• Keep abreast of current industry trends, compliance requirements, and best-of-class technologies.

Benefits

• 401(k) matching
• Dental insurance
• Disability insurance
• Flexible spending account
• Free parking
• Health insurance
• Life insurance
• Gym subsidy
• Tuition assistance
• Paid time off including holidays and sick leave

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: High school or GED