QA Specialist IV, Plant Operations-Investigations (Hybrid)

Partner Therapeutics • WA

105d • $112,000 - $130,000

About The Position

The QA Specialist IV, Plant Operations-Investigations partners with individuals and cross-functional teams throughout the Northpointe site to perform investigations, author investigation reports, author CAPA plans, manage CAPA records and implement improvements to Quality Systems processes and workflows. This position will provide oversight of the processes for Deviations, Change Management, Training, and Document Management to ensure continuous conformance with appropriate standards and regulations.

Requirements

• High School Diploma or GED.
• 8+ years of progressively responsible experience working in a GMP environment or other regulated industry.
• Experience with Quality Management Systems, TrackWise or MasterControl.

Nice To Haves

• Bachelor’s degree in Science related field or equivalent industry experience.
• Biotech/Pharmaceutical manufacturing experience strongly preferred.
• Software application experience with Smartsheet, MS Project, and SharePoint.
• Project management skills or formal training.

Responsibilities

• Leads quality investigations and CAPAs.
• Determines accurate root causes of problems and supports implementation of effective short term and long term CAPA to address the identified cause.
• Acts as a point of contact for investigations and CAPAs.
• Authors investigation reports and CAPA plans.
• Completes review and approval of compliance documents including SOPs, Deviations, Change Controls, Validation, Quality records, and other documentation required for compliant GMP Production.
• Participates in QA on-the-floor activities to ensure successful partnering with functional areas.
• With support from department leadership, builds skill to interpret complex, explicit documentation for new and current compliance procedures and FDA enforcement action/trends.
• Partners with functional groups as the point of contact for specific quality issues and completes walk-throughs of areas while providing feedback and fostering a collaborative relationship.
• Mentors and trains other quality team members.
• Supports the development and maintenance of Quality Standards and Policies.
• Supports Quality System continuous improvement activities for ongoing compliance initiatives to promote sustainable compliance.
• Partners with owning department to ensure on-time closure of Quality records.
• Updates Standard Operating Procedures (SOPs) and other documents as required.
• Participates in regulatory inspections acting as required. Provides audit and inspection support, either as a Subject Matter Expert or in front room or back room support.
• Resolves 'stuck' issues by ensuring timely issue escalation to Leadership and cross-functional teams: Applies learning from these events and leads the creation of new/updated systems, processes, programs to prevent similar situations in the future.
• Through self-education and external networking/participation in industry and professional organizations keeps abreast of current industry trends, compliance requirements, and best-of-class technologies relating to area of responsibility. Actively applies learned best practices, knowledge, and benchmarking to PTx projects and solutions.
• Pursues participation or leads project teams outside normal course of work (i.e. 'collateral duties') as they become available to support personal growth, connection, and business needs.
• Adheres to all applicable regulations and requirements including compliance with internal SOPs, GMP, Health and Safety, WISHA/OSHA, regulatory compliance, company policies, and employment-related laws and statutes.
• Successfully completes all mandatory Quality and Compliance training within required timeframes.

Benefits

• Medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage.
• Casual, Hybrid or Remote workplace program for many roles.
• Pre-IPO options.
• Annual cash bonuses.
• 401k matching.
• Free parking or Seattle-area ORCA pass.
• Tuition assistance.
• Rewards for achievement and contribution.
• Gym subsidy.
• Wellness participation programs.
• Generous vacation, sick, and holiday paid time off program.
• Paid shutdown between the Christmas and New Year’s holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 101-250 employees