Provide Quality and Compliance support for assigned Facilities Operations, Validation, Engineering and Compliance in the AMR region.
Provide direct support and guidance for all Facilities compliance activities conducted within Manufacturing and related Operations.
Partner in process improvement and global alignment Facilities compliance projects.
Collaborate with departments to ensure compliance activities are executed efficiently and effectively, and in accordance with all governing documents and external guidelines.
Interacts constructively with employees, managers and cross-functional peers.
Team member helping and interfacing with suppliers to deliver product meeting our quality requirements.
Manage competing priorities and allocate and optimize time to ensure targets and timelines are met.
Serve as a subject matter expert (SME) in support of department functions.
Develop, mentor, and train personnel and internal customers on relevant business processes.
Contribute to continuous quality improvement efforts to conform to regulatory requirements and industry standards.
Conduct quality-related activities to deliver consistent, high quality documents, services, products and processes, which adds value to the business.
Key player in global document alignment and restructuring initiative.
Provides compliant solutions to a variety of problems of moderate to advanced scope and complexity.
May lead a project with a limited scope, but usually a contributor on broader projects.
Coordinates quality decisions between different quality and engineering groups.
Maintains awareness of standards that regulate our industry (ISO 13485 2003 & 2016; 21 CFR 820).
Supporting and conducting internal audits of Facilities teams (Americas & Global)
Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate.
Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
Ensures compliant documentation related to area of responsibility.
Receives general direction and exercises considerable discretion to own work detail.
Ensures compliant documentation, carrying out tasks related to area of responsibility with management oversight.
Implement approved action plan related to existing or missing documents
CAPA management from initiation through effectiveness check including immediate containment, risk assessment and mitigation, root cause analysis, action plan development and implementation and ensuring of successful effectiveness check phase activities.
Partake in cross-functional and cross-site relationships with Manufacturing, technical support groups, and R&D for root cause analysis, problem resolution and system/program optimization.
Applies basic to moderate Risk Management principles to work.
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.
Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
Interprets internal/external business challenges and recommends best practices to improve products, processes or services.
Review and provide expertise on Facilities & BMS change control, CAPA, and other supporting documentation.
Determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead).
Serve as a subject matter expert (SME) in support of department functions. Develop, mentor, and train personnel and internal customers on relevant business processes.
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:
Ability to interpret and relate quality standards (ISO 13485 & 21 CFR 820) for implementation and review.
Sound knowledge of and ability to make sound cGMP decisions, allocation of resources, and managing priorities
Ability to communicate clearly and professionally both in writing and verbally.
Flexibility in problem solving, providing direction and work hours to meet business objectives.
Ability to work independently and cross-functionally in a dynamic environment.
Strong time management and prioritization skills to manage multiple projects with critical, FDA enforced, deadlines and tight budgets.
Must have experience working in n Quality Internal Audit role (focus: Facilities), or a Facilities Compliance, Validation, Operations, or Engineering role.
A broad understanding of Facilities-related subject matters is required.
Understanding of internal audit process, and approach would be beneficial to this role. Internal audit focus on Facilities would be ideal.
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities
Experience/Education:
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.
Education: B.A. or B.S. degree (preferably in Life Science or Engineering), and at least 5 years of experience in the medical device, pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience
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. 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
