Sr Quality Assurance Specialist

At Roche, we believe it’s critical to deliver medical solutions now – even as we develop innovations for the future. We are passionate about transforming patients’ lives and we are fearless in both decision and action. And we believe that good business means a better world.

That is why we come to work each day. We commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

You’ll be working within the Processes Domain Group. Together with the Technology Area of Practice it owns the technology strategy, the operations and the delivery according to the roadmap with the aim to to maximize the contribution to the 2030 ambitions.

Purpose

You will be a senior quality assurance specialist professional who thoroughly understands how GenMark’s CAPA Management System and associated processes work optimally together. A self-starter with solid customer and stakeholder awareness, you should be capable of supporting the management, oversight, and timely closure of Issue Reviews, Corrective and Preventive Actions (CAPA), quality events from escalated complaints and field data, and internal and external audits and inspections.

You will represent Quality Assurance, be a creative problem solver and critical thinker, and create collaborative relationships across the organization.

Career Opportunities

• You will provide QA review, approval, and oversight on the timely closure of Issue Reviews, Corrective and Preventive Actions (CAPA), and quality events from escalated complaints and field data, and internal and external audits and inspections.
• You will support in managing CAPAs and providing project management oversight of the CAPAs to ensure all required corrective actions remain on track and are closed by assigned due dates.
• You will provide QA guidance and training on Issue Review and CAPA processes and system requirements. Lead QA on GenMark-Roche integration activities associated with CAPA subsystems and processes.
• You will support in the coordination of any potential Field Corrective Actions and facilitation of Product Quality Committee meetings for escalated quality events.
• You will lead QA on facilitating and documenting Product Quality Committee meetings and actions associated with quality events escalated from complaints and field data.
• This role may serve as a back-up to the QA Manager on GMP decisions and delegated signatory for GMP approval.
• You will conduct timely information gathering sessions with cross-functional departments to obtain required information and data to complete an Issue Review risk assessment and CAPA investigation.
• You will assess and support the product impact during Issue Review risk assessments and within the CAPA investigation. Coordinates and documents the execution and/or participation of risk assessment evaluations into product issues.
• You will conduct thorough root cause analysis and support investigators in documenting the investigation including causal factors identified and any root causes determined.
• Based on root cause outcome, support in identifying appropriate corrective actions and preventive actions (CAPAs) and effectiveness checks.
• You will review historical data and any similar events to evaluate trends or patterns for potential systemic issues.
• Stakeholder in the development, implementation, and continued improvement of the Issue Review and CAPA systems and processes. Support process improvement activities as required, including leading changes and aiding in implementation of process improvements with respect to quality processes.
• Lead and/or contribute to system, product and process improvement projects. Participation in process improvements associated with investigation processes may be required.
• Additional responsibilities may include cross-training as a Quality Representative to close investigations from other investigators and to close other reports in multiple quality systems.
• Support external agency and internal audits, and serve as subject matter expert on Quality System processes, as needed.
• Other duties as assigned, according to the changing needs of the business.

Qualifications and Experience

Minimum Requirements:

• Bachelor of Science in related industry
• Minimum of 5 year of quality experience working in an FDA regulated environment and in the IVD industry
• Experience with eQMS

Skills – Technical

• Proficient in Microsoft Office, especially Word and Excel, for editing and tracking documents.
• Proficient in Google docs or using SmartSheets
• Experience with electronic Quality Management Systems (preferably Master Control)
• Experience working with cross-functional areas (e.g., Manufacturing, Operations, Regulatory Affairs, Engineering)
• Position requires technical writing capabilities to create clear, concise investigations with appropriate details.

Skills – General

• Must be a hands-on, self-directed, detail oriented and conscientious individual
• Ability to work independently with minimal supervision.
• Time management skills are essential as investigators will be required to own and manage multiple investigations or CAPAs and adhere to assigned due dates and tight timelines.
• Effective analytical problem solving, judgment and decision-making skills are required
• Ability to work and collaborate with staff from all departments is required.
• Complete work in a timely, accurate and thorough manner.
• Strong time management and organizational skills in a dynamic, constantly changing environment.
• Ability to read, write and analyze complex documents.
• Proven ability to prioritize responsibilities in a high pressure, dynamic, multi-tasking environment.
• Ability to respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, peers and individuals.
• Ability to work effectively, exhibit a professional manner and establish constructive working relationships.
• Proven and effective interpersonal communication skills with a demonstrated ability to interact with internal customers in a positive, friendly, and professional manner.
• Excellent presentation skills.
• Adept at influencing, gaining consensus, and capable of overcoming resistance by presenting a powerful case for implementing new initiatives or ideas.

Preferred Requirements:

• Experience eQMS Master Control, SAP, ERP system
• CQE, CQA, or relevant certification, license, or registration

*Relocation assistance is NOT available for this role*

The expected salary range for this position based on the primary location of California is $85,400.00 to $158,600.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark’s ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.