Job details
Job type full-time
Full job description
Quality assurance specialist
Partner therapeutics is a commercial biopharmaceutical company committed to improving the lives of patients with cancer and other serious diseasesOur dedicated team brings a rigorous approach to science, establishes deep partnerships with medical and scientific communities, and works tirelessly to expand potential treatment options and address unmet medical needs.
Position overview
The quality organization ensures the safety, efficacy, purity, and quality of manufactured products through compliance with cgmps, regulations and established procedures.
The quality assurance 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 automationAdditionally, 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 workflowsThis position will provide oversight of the processes for deviations, change management, training, and document management to ensure continuous conformance with appropriate standards and regulations.
Key responsibilities
Author investigation reports and capa plans
Act as a point of contact for investigations and capas
Completes review and approval of compliance documents including sops, deviations, change controls, quality records and other documentation required for compliant gmp production.
Determine accurate root causes of problems and support implementation of effective short term and long term capa to address the identified cause
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.
Support 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 sop and other documents as required
Participates in regulatory inspections acting as required
Attend key conferences and industry group meetings/discussions
Qualifications
Bachelor’s degree in science or equivalent industry experience.
1+ years experience working in a gxp environment or other regulated industry
Strong written and verbal communication skills
Some experience in technical writing and ability to author clear, concise, and technically accurate documentation
Interpersonal and professional skills to interact and build relationships with users and technical staff.
Preferred qualifications
Experience with root cause analysis tools (e.g5 why’s, comparative analysis, ishikawa)
Experience with electronic quality systems (e.gTrack wise, mastercontrol)
Experience using risk-based thinking or risk-based tools
Independently seeks knowledge and solutions to problems from all available sources.
Has some experience developing well designed plans that consider sequence, relationship and timing of dependencies
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 rolesWe 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 contributionTo 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 lawThis policy applies to all aspects of employment, including recruitment, placement, promotion, transfer, demotion, compensation, benefits, social and recreational activities, and termination.
Job type: full-time
Work location: multiple locations
