Partner Therapeutics

QA SPECIALIST IV, PLANT OPERATIONS-INVESTIGATIONS (HYBRID)

POSITION SUMMARY

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. 

PRIMARY RESPONSIBILITIES

• Leads quality investigations and CAPAs.
• Determines accurate root causes of problems and support 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.
• This job description is not intended to be all-inclusive. Partners may be required to perform other related duties to meet the ongoing needs of the organization.

KNOWLEDGE, SKILLS, ABILITIES

Required:

• Analytical Thinking: Ability to evaluate complex deviations and distill them into clear, defensible investigation reports.
• Technical Writing: Skilled at drafting clear, concise, and scientifically sound investigation reports, CAPAs, and regulatory responses.
• Problem-Solving: Strong critical thinking, analytical, and problem-solving skills with the proven ability to formulate solutions to propel the organization forward. Proven ability to lead root cause analysis and propose effective, sustainable corrective actions Skilled at 5 Why’s comparative analysis, Ishikawa.
• Collaboration: Resourceful with proven ability to lead, manage, and leverage an extensive internal network of stakeholders, team members, and external resources to plan and resolve issues.
• Works effectively across functions (Manufacturing, Engineering, QC, Validation).  Networks with key contacts outside own area of expertise.
• Decision-Making: Applies risk-based thinking to recommend timely solutions to complex investigational issues requiring in-depth analysis of variable factors.
• Communication: Strong written and oral English communication skills are required for this highly collaborative role. Proven ability to make clear, effective, and persuasive presentations to audiences at various levels of expertise required. Skilled at leading effective meetings and communicating technical and compliance issues to leadership and regulators.
• Quality Risk Management: Knowledge of ICH Q9 Principles for risk assessment and mitigation. Skilled at using risk based thinking or risk based tools.
• Skilled developing well designed plans that consider sequence, relationship and timing of dependencies.
• Possesses strong organizational and prioritization skills to maintain a high level of productivity and priority-setting in order to complete assignments on-time and on-budget.
• Excellent soft skills including a bias towards action, the ability and willingness to give and receive constructive feedback, is comfortable working within a diverse team and across multiple functions, exhibits a consistently constructive attitude, and is adaptable and at ease with handling unexpected change and challenges.
• Solid software skills essential including Word, Excel, PowerPoint, and Outlook; ability and willingness to quickly adopt other job-specific applications will be necessary.

Preferred:

• Software application experience with Smartsheet, MS Project, and SharePoint.
• Project management skills or formal training.

EXPERIENCE & EDUCATION

Required:

• 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

Preferred:

• Bachelor’s degree in Science related field or equivalent industry experience.
• Biotech/Pharmaceutical manufacturing experience strongly preferred.

PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for this position is $112,000 - $130,000: Offers are made within the base pay range applicable at the time. Your salary will vary depending on several factors including your qualifications and experience.

In addition to medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage, all full-time, regular Partners enjoy a casual, and Hybrid or Remote workplace program for many roles.  We offer a terrific compensation/benefits/perks package which includes pre-IPO options, annual cash bonuses, 401k matching, free parking or Seattle-area ORCA pass, tuition assistance, plus rewards for achievement and contribution. To support a healthy work-life balance we also provide a gym subsidy, wellness participation programs, and a generous vacation, sick, and holiday paid time off program in addition to a paid shutdown between the Christmas and New Year’s holidays.  

Partner Therapeutics is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, age, national origin, veteran status, marital status, sexual orientation, gender identity, disability or any other category prohibited by local, state, or federal law. This policy applies to all aspects of employment, including recruitment, placement, promotion, transfer, demotion, compensation, benefits, social and recreational activities, and termination.