Facilities Compliance Specialist 1 at Illumina

San Diego, California, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Genomics, Life SciencesIndustries

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

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 (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
Collaborate 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

Skills

Key technologies and capabilities for this role

Facilities ComplianceQuality ManagementGap AnalysisSOP ReviewProcess ImprovementTeamcenterCompliance MetricsIssue EscalationValidationEngineering Support

Questions & Answers

Common questions about this position

Is this a full-time position?

Yes, this is a full-time employment opportunity.

Where is this role primarily located?

The role has a primary focus in San Diego within the AMR facilities organization.

What key skills are needed for the Facilities Compliance Specialist role?

The position requires strong competency and expertise in Facilities-related Compliance requirements, ability to conduct gap analysis and evaluations, track compliance activities and metrics, review and revise SOPs and Work Instructions, support failure investigations, CAPAs, NCRs, and audits.

What is the company culture like at Illumina?

Illumina fosters a collaborative environment where every person has the opportunity to make a difference, surrounded by extraordinary people, inspiring leaders, and world-changing projects, with emphasis on teamwork, leadership, mentoring, and achieving the highest level of quality and service.

What makes a strong candidate for this position?

A strong candidate demonstrates proven expertise in Facilities compliance, experience with process improvements, CAPAs, audits, SOP revisions, and the ability to provide leadership and cross-functional collaboration.

Illumina

Supports genomics startups through funding and resources

About Illumina

Illumina focuses on fostering innovation in the genomics industry by supporting startups through its Illumina Accelerator program. This program helps entrepreneurs create, launch, and grow genomics-focused companies by providing funding and resources. The accelerator operates in two main locations: the San Francisco Bay Area and Cambridge, UK. Illumina Accelerator has successfully invested in 68 genomics startups, which have collectively raised over $1 billion in venture capital. What sets Illumina apart from its competitors is its strong partnership with leading venture capital investors and its dedicated focus on the genomics sector. The goal of Illumina is to build a thriving ecosystem for genomics innovation, enabling new companies to emerge and advance the field.

San Diego, CaliforniaHeadquarters

1998Year Founded

$27.2MTotal Funding

IPOCompany Stage

Venture Capital, BiotechnologyIndustries

5,001-10,000Employees

Risks

Over-reliance on NVIDIA's AI technology may limit flexibility in AI solution adoption.

Standardizing proteomics data across platforms could challenge Illumina's data reliability.

Single-flow-cell NovaSeq X System might cannibalize sales of higher-end models.

Differentiation

Illumina leads in genomic sequencing with advanced AI integration and multiomic data analysis.

The company offers innovative array-based solutions for DNA, RNA, and protein analysis.

Illumina's global expansion includes a new Global Capability Center in Bengaluru.

Upsides

Collaboration with NVIDIA enhances drug discovery and clinical development through AI integration.

Pilot proteomics program with UK Biobank aims to generate crucial reference datasets.

Single-cell sequencing kits make high-throughput sequencing accessible to smaller labs.

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