Facilities Compliance Specialist 1

Illumina • San Diego, CA

34d

About The Position

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.

Requirements

• Experience in a cGMP environment.
• 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.
• 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.
• 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.

Nice To Haves

• Knowledge of ISO 13485 - Medical Device Standard a plus
• Knowledge of Environmental Controls, Preventive Maintenance, Calibration and Building Automation Systems is a plus.
• Knowledge of SAP EAM, Teamcenter, Valgenesis, and EtQ is a plus
• Experience with internal or external quality audits is a plus

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
• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Computer and Electronic Product Manufacturing
• Number of Employees: 5,001-10,000 employees