Quality Systems Specialist I

Bio-Rad Laboratories, Inc; Irvine (CA); On-site; USD 70,000 - 85,000; Full time

Job summary

Bio-Rad Laboratories, Inc in Irvine, CA is seeking a Quality System Specialist I to support our Quality Management System and ensure documentation, record scanning, and archive records are kept up to date.

You will assist with change requests, provide training coordination, document control, Veeva eQMS familiarity, and data processing in SAP, contributing to process improvements and regulatory compliance.

Qualifications

• Education: High School Diploma or equivalent.
• Work Experience: 0+ years in a regulated industry or equivalent combination of education and experience.
• Proficient with various software including, but not limited to, Microsoft 365 Suite, Adobe Acrobat, SmartSheet, Visio, SAP, etc. Experience with Veeva eQMS software is a plus.
• Detail oriented and ability to multitask.
• Basic understanding of GMP and quality system standards desirable.

Responsibilities

• Maintain the Quality Management System (QMS) by ensuring quality documentation, records management, and scanning activities are completed accurately and on time.
• Support Quality Coordinator functions, including Training Coordination, Document Control, Veeva support, and SAP data processing.
• Process and coordinate quality system changes to ensure compliance with procedures and regulatory requirements.
• Perform data entry, tracking, reporting, and record management to maintain accurate quality records and metrics.
• Assist with process improvement initiatives and collaborate with cross-functional teams to enhance efficiency, compliance, and effectiveness.

Skills

Microsoft 365

Adobe Acrobat

SmartSheet

Visio

SAP

Veeva eQMS

Education

High School Diploma or equivalent

Tools

SAP

Job description

As the Quality System Specialist I, you will support Bio-rad’s commitment to quality and safety by helping maintain the Quality Management System. As part of the Quality Assurance team, you’ll apply your skills in multi-tasking and attention to detail to help ensure documentation and record scanning is up to date, archive records are maintained, change requests are processed, and process improvements are implemented.

How You’ll Make an Impact:

• Maintain the Quality Management System (QMS) by ensuring quality documentation, records management, and scanning activities are completed accurately and on time.
• Support Quality Coordinator functions, including Training Coordination, Document Control, Veeva support, and SAP data processing.
• Process and coordinate quality system changes to ensure compliance with procedures and regulatory requirements.
• Perform data entry, tracking, reporting, and record management to maintain accurate quality records and metrics.
• Assist with process improvement initiatives and collaborate with cross-functional teams to enhance efficiency, compliance, and effectiveness.

What You Bring:

• Education: High School Diploma or equivalent.
• Work Experience: 0+ years in a regulated industry or equivalent combination of education and experience.
• Proficient with various software including, but not limited to, Microsoft 365 Suite, Adobe Acrobat, SmartSheet, Visio, SAP, etc. Experience with Veeva eQMS software is a plus.
• Detail oriented and ability to multitask.
• Basic understanding of GMP and quality system standards desirable.

Location:

This position must be based in Irvine, CA and requires the employee to be located within commuting distance of the office.

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:

• 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 $70,310 to $85,300 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 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. 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.