Senior Quality Specialist page is loaded
Senior Quality Specialist
Apply locations US - Bay Area - Foster City US - California - San Diego time type Full time posted on Posted 3 Days Ago job requisition id 40530-JOB What if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.Responsibilities:
Manage the document control program as well as suggest and implement improvements to existing processes.
Analyze and process Change Requests (CRs) and Change Orders (COs) in Ensur.
Write, edit, review, and maintain procedural documentation including, but not limited to, department policies, procedures, and guidance documentation at Illumina Laboratory Services (ILS).
Perform document processing, distribution of controlled copies, and filing using manual and electronic systems per established procedures.
Monitor change activities approval/implementation and resolve issues of varying complexity.
Facilitate record management, including maintenance for retention periods. Ensure compliance with appropriate regulations.
Onboard/offboard employees in the Ensur system.
Provide training for the Ensur system, Quality Systems New Hire Orientation, and Document Controls process, as needed.
Maintain personnel records in the system.
Assign document training as per management request based on the department training matrix/training plan.
Create and maintain training matrices for the organization with collaboration from management.
Support tracking, trending, and reporting of document training.
Communicate and conduct training as needed for users.
Manage or support the training program as well as suggest and implement improvements to existing processes.
Support the tracking and review of competency assessments and the training records review process.
Provide Ensur system administration support throughout the organization, resolving issues, answering questions, and fulfilling custom requests.
Support the administration and validation of upgrades of the Ensur System.
Work with the software provider (DocXellent) to resolve issues, for custom requests, and to coordinate software updates/upgrades.
Interface with internal and external customers to convey requirements and resolve issues to drive efficient and effective processes.
Prioritize and coordinate tasks and projects within a fast-paced environment.
Ensure standard practices and procedures are followed when analyzing data and content.
Escalate issues and risks to management, as appropriate.
Monitor documentation system performance. Generate Quality Indices and feedback for continuous improvement.
Drive best practices throughout the organization.
Perform trending analysis (Quality Metrics) on an as-needed basis, including using statistical process control methods.
Participate in internal and external audits, nonconformity investigations, and CAPA investigations, as needed.
Work with management to improve quality system policies and procedures.
Participate in global projects supporting all 3 sites, as needed.
Assist in internal and external audits, as needed.
Collaborate deeply with cross functional teams to implement new processes and promote awareness and adherence to policy and procedures
May include other duties as defined by the department Manager.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Requirements:
Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience
B.S. Degree in Molecular Biology or related field plus 5 years of industry experience; in vitro diagnostic or molecular reagent quality assurance is preferred
5-8 years of direct work experience in QA, including all aspects of device/diagnostic quality systems
Experience understanding and applying quality system regulations and standards, including GDP, FDA, CLIA, CAP, NYSDH, ISO 13485 and/or CFR Part 820 and Part 11 is a plus
Excellent problem solving and analytical skills.
Effective interpersonal and communication skills and capable of supporting cross-functional project goals.
Experience in MS Word, Excel, Lucid charts and PowerPoint required to conduct data analysis/ data trending and assist in developing process maps and procedures
Quality engineering experience is a plus.
Must be team oriented and have effective communication skills to work as part of a team
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
The estimated base salary range for the Senior Quality Specialist role based in the United States of America is: $101,000 - $151,600. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.
About Us
The potential of genomics to change the world is unparalleled. At Illumina, we are leading the way. Our technology empowers researchers and clinicians globally to improve cancer treatments, change the course of diseases, protect the environment, and fight food insecurity. We are made up of dedicated professionals, all-in on creating a better world – and we need every skill set on our path to making genomics useful for all. Learn more about life at Illumina.