Partner Therapeutics

QUALITY ASSURANCE SPECIALIST II (HYBRID)

POSITION SUMMARY

The Quality Assurance Plant Operations department provides QA oversight of the systems and procedures governing the GMP activities at the Northpointe facility including Production, Validation, Quality Control, Engineering, and Automation. Additionally, the department 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 support documentation review, equipment review, deviation evaluation, and QA oversight on the floor.

PRIMARY RESPONSIBILITIES

• Leads/writes deviation evaluation meetings/records and determines if escalation to CAPA is appropriate.
• Participates in Root Cause Analysis and development of CAPA plans and supports implementation of effective short term and long term CAPA to address the identified cause.
• Completes review and approval of compliance documents including SOPs, Deviations, Validation Documents, Trend Reports, 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 skills 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.
• Supports the development and maintenance of Quality Standards and Policies.
• Supports Quality System continuous improvement activities for ongoing compliance initiatives to promote sustainable compliance.
• Updates SOPs and other documents.
• Participates in regulatory inspections.
• 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 as required to meet the ongoing needs of the organization.

KNOWLEDGE, SKILLS, ABILITIES

Required:

• Skilled with electronic Quality Systems (e.g. MasterControl, Maximo preferred).
• Familiarity with Root Cause Analysis tools (e.g. 5 why’s, comparative analysis, Ishikawa).
• Proven ability to independently seek knowledge and solutions to problems from all available sources.
• Proven ability to author clear, concise, and technically accurate documentation.
• 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 changes and challenges.
• Solid English language communication skills, both oral and written, are required for this highly collaborative role. Willingness and ability to clearly express opinions and ask questions.  Comfortable actively participating in cross-functional meetings.
• Solid software skills essential including Word and Outlook; ability and willingness to quickly adopt other job-specific applications will be necessary.

Preferred:

• Familiarity with risk-based thinking or risk-based tools.
• Experience participating in the development of well-designed plans that consider sequence, relationship and timing of dependencies.
• Software expertise in Excel, PowePoint, and SharePoint.

EXPERIENCE & EDUCATION

Required:

• High School diploma or GED.
• 2+ years of progressively responsible, relevant experience working in a GxP environment or other regulated industry.

Preferred:

• B.S. or equivalent degree in science (Biology, Chemistry, Biochemisty, etc.) or related field (Chemical Engineering, etc.) strongly preferred.
• 3+ years of experience in a Quality role optimal.

PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for this position is $85,400 -$99,486: 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.