Facilities Compliance Specialist 1

San Diego, CA - USA

Monthly Salary: $ 61700 - 92500

Posted on: 14 hours ago

Vacancies: 1 Vacancy

Job Summary

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.

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 quality document management in Teamcenter
Review and revise Standard Operating Procedures (SOPs) 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 Nonconformances (NCs) Quality Investigations and Audit Findings
Support Non-Conformance Records (NCRs) 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 (ISOCFR Part 820 & 21 CFR Part 11) for implementation and review
Strong technical and quality writing skills for use in creating and revision of SOPs & in writing investigations and action plans for CAPAs & NCs.
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 bachelors 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: $61700 - $92500. 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 individuals 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.

We are a company deeply rooted in belonging promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation Illumina has always prioritized openness collaboration and seeking alternative 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 offer opportunities to engage in social responsibility. 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. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process please contact To learn more visit: 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.

Required Experience:

What if the work you did every day could impact the lives of people you know Or all of humanityAt 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 t...