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Facilities Compliance Specialist 1 - US1


Position Summary:

The Facilities Compliance Specialist works within the Facilities Compliance team and is supported with leveling up our quality maturity within the AMR facilities organization with primary focus in San Diego. Provide Compliance support for assigned Facilities Operations, Validation, and Engineering in the AMR region. Provide direct support and guidance for all Facilities compliance activities conducted within Manufacturing and related Operations. Support in process improvement and global/regional alignment Facilities compliance projects.

Responsibilities:

• Demonstrate strong competency and expertise in Facilities-related Compliance requirements and a proven ability to provide value-added support to fulfill business objectives
• Support gap analysis and ongoing evaluations of Facilities operations to achieve and sustain compliance
• Track Facilities compliance activities, monitor metrics, and oversee issue escalation
• Responsible for assessing impacts and implementing changes to site-level Facilities processes and procedures in Teamcenter
• Review and revise Standard Operating Procedures (SOP's) and Work Instructions related to Facilities operations. Ensure compliance to site level procedures, global policies, and applicable regulations
• Support failure investigations and create reports pertaining to process deviations.
• Drive and own facilities related CAPAs, Nonconformance's (NCs), Quality Investigations and Audit Findings
• Support Non-Conformance Records (NCR's) for equipment/systems out of tolerance conditions; support internal and external audits; contribute as needed in FDA, FM Global, UL and any other third-party audits
• Develop and execute audit response plans for timely completion of internal and external audit actions
• Provide administration for Facilities responsibilities related to a real-time validated environmental monitoring, alarming, and reporting data tracking system.
• Partner with the Quality Function to meet shared compliance goals
• Collaborative cross functionally to support Global Facilities strategic initiatives
• Provide leadership, mentoring and guidance to the Facilities technicians and Engineering to ensure the highest level of quality, service and courtesy are always implemented.
• Performs other related duties as required or requested.
• Support Quality Plans as they pertain to Facilities Operations
• Generate KPI/metrics reports

Requirements:

• Experience in a cGMP environment.
• Knowledge of ISO 13485 – Medical Device Standard a plus
• Ability to interpret and relate quality standards (ISO 13485, 21 CFR Part 820 & 21 CFR Part 11) for implementation and review
• Strong technical and quality writing skills for use in creating and revision of SOP’s, & in writing investigations and action plans for CAPA’s & NC’s.
• Knowledge of Environmental Controls, Preventive Maintenance, Calibration and Building Automation Systems is a plus.
• Ability to analyze facilities problems and recommend solutions.
• Energetic team player with strong interpersonal skills, capable of working within a diverse, cross-functional, internal, and external team.
• Experience working in office, manufacturing, and warehouse environments.
• Working expertise in MS Office Suite and industry-related software.
• Knowledge of SAP EAM, Teamcenter, Valgenesis, and EtQ is a plus
• Experience with internal or external quality audits is a plus

Education & Experience:

• Preferably a bachelor’s degree
• At least 0-2 years of experience in the medical device, pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.

The estimated base salary range for the Facilities Compliance Specialist 1 role based in the United States of America is: $61,700 - $92,500. 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.