Field Action Specialist

As the Field Action Specialist, you will support correction and removal (field action) activities in accordance with applicable regulatory requirements and international standards (FDA, MDSAP, ISO 13485, etc.).  This includes coordinating with product segments, global business unit Regulatory Affairs, Quality Assurance, Global Distribution, and Commercial Operations organizations to ensure timely and effective communication and coordination of field actions including customer communications, and product stop shipments and containment. 

This is a remote position. 

How You'll Make An Impact:

• Facilitating the Bio-Rad Laboratories Event Investigation Board (EIB) including establishing meeting agendas, chairing the meeting, publishing meeting minutes, and recording/tracking action items.
• Maintaining the master list of field actions and management/ownership of related KPI dashboards (PowerBI, SmartSheets, etc.).   
• Analyzing and preparing regular reports for management review as needed. 
• Supporting the creation, routing, and approval of field action documentation including, but not limited to, customer notifications, communications with regulatory bodies, and internal stakeholders. 
• Collaborating with manufacturing unit stakeholders to ensure required field action documentation and supporting activities are accurately prepared prior to review at the EIB.  
• Working with global RA/QA stakeholders to identify and implement process improvements related to the field action program and related quality system processes. 
• Supporting system automation and integration with eQMS processes. 
• Maintaining the Bio-Rad Global Field Action Procedure and ensuring that it is aligned to all applicable regulations and standards. 
• Driving continuous improvement and operational efficiency.
• Working with internal and external stakeholders to document field actions.
• Facilitate weekly meetings to ensure timely status updates are provided to global management.
• Partner with stakeholder to create, review and approve communications and corrective action plans and provide individual follow ups as needed.
• Identify process improvements and work with stakeholders to implement as needed.
• Support for system automation and integration with eQMS processes.

What You Bring:

• Bachelor’s degree or equivalent in a related life science/technical discipline or equivalent preferred. 
• 5+ years experience in a regulated manufacturing industry or equivalent combination of education and experience. 2+ years experience supporting field action processes. 
• Advanced understanding of GMP and quality system standards as they apply to products manufactured by Bio-Rad. 
• Working knowledge of device/drug/biotech manufacturing processes.
• Experience developing, maintaining and presenting process and quality system metrics. 
• Advanced knowledge of ISO 13485, 21 CFR 820, 806, 810 and MDSAP. 
• Knowledge of (EU) 2017/746 (IVDR) preferred. 
• Detail-oriented and ability to multitask. 
• Strong problem solving, decision making, time management, organization, communication, leadership, and computer skills. 
• Advanced technical writing and word processing skills.

Total Rewards Package: At Bio-Rad, we’re empowered by our purpose and recognize that our employees are as well.  That’s why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle.

Benefits: We’re proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG’s), and more!  

Compensation: The estimated base salary range for this position is $83,000 - $140,500 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is also eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.

Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it.  #LI-AK1 #LI-remote