Quality System Specialist II- Temporary

Tri-Valley Career Center; Hercules (CA); On-site; USD 48,216 - 60,614; Part time

Job summary

Bio-Rad is seeking a qualified professional to support risk management activities, update hazard analyses, and coordinate cross‑functional input for comprehensive risk profiles. The role includes migrating risk files to the eQMS, ensuring metadata accuracy, and addressing gaps relative to IVDR guidance while maintaining adherence to GMP/ISO standards.

The position requires an associate degree and 2+ years in regulated manufacturing or equivalent experience, with strong organizational and

Qualifications

• Associate degree in Biology, Chemistry, Engineering or related field.
• 2+ years experience in regulated manufacturing or equivalent education and experience.
• Knowledge of GMP/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211).
• Familiarity with device/drug/biotech manufacturing processes.
• Detail‑oriented with strong organizational, project management, multitasking abilities.
• Skills in decision making, time management, communication, and computer use.
• Proficient in Microsoft Office, Visio, and Excel.
• SalesForce, Veeva, EtQ and/or SAP experience are desirable.
• Experience in product design and development and risk management a plus.

Responsibilities

• Facilitating risk management assessments, updating risk plans and reports, and consolidating and updating product system hazard analysis files in accordance with established company procedures and applicable standards.
• Coordinating and facilitating meetings with cross‑functional stakeholders to gather information for risk profiles and identify new risks, escalating to Management as needed.
• Supporting migration of product risk management files into the eQMS system and ensuring accurate metadata and linking to legacy DHF binders.
• Assessing legacy technical and risk documentation and identifying gaps relative to IVDR transitional activities vs new guidance.
• Supporting other IVDR‑related technical documentation updates and gap assessments, including migration into eQMS (document scanning, etc.).
• Working in a dynamic environment with cross‑functional teams, showing ownership and accountability for tasks.

Skills

Detail-oriented

Organizational skills

Project management

Multitasking

Decision making

Time management

Communication

Computer literacy

Education

Associate degree

Tools

Microsoft Office

Visio

Excel

SalesForce

Veeva

EtQ

SAP

Job description

Responsibilities

• Facilitating risk management assessments, updating risk plans and reports, and consolidating and updating product system hazard analysis files in accordance with established company procedures and applicable standards.
• Coordinating and facilitating meetings with cross‑functional stakeholders as necessary to gather information and data required for the completeness and accuracy of risk profiles for existing hazards, and identifying new risks and hazards as needed. Escalating events to Management that require additional inputs or mitigations.
• Supporting the migration of product risk management files into the eQMS system, ensuring document metadata is accurate and files are correctly linked to legacy product DHF binders in coordination with DHF migration efforts.
• Assessing legacy technical and risk documentation and identifying gaps relative to initial IVDR transitional activities versus new guidance documents and updates to global quality management procedures.
• Supporting other IVDR‑related technical documentation updates and gap assessments as required, including identification of legacy design and development documentation and migration into eQMS as necessary (document scanning, etc.).
• The candidate must possess the ability to work in a dynamic environment and demonstrate a high level of patience to support cross‑functional teams with shifting priorities. The individual should be self‑motivated, able to work independently, and have a sense of ownership and accountability for the tasks assigned.

Qualifications

• Associate degree in Biology, Chemistry, Engineering or a related field.
• 2+ years experience in regulated manufacturing or equivalent education and experience.
• Knowledge of GMP/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211).
• Familiarity with device/drug/biotech manufacturing processes.
• Detail‑oriented with strong organizational, project management, multitasking abilities.
• Skills in decision making, time management, communication, and computer use.
• Proficient in Microsoft Office, Visio, and Excel.
• SalesForce, Veeva, EtQ and/or SAP experience are desirable.
• Experience in product design and development and risk management a plus.

Compensation

The estimated hourly range for this position is $35 to $44 per hour 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. As a temporary associate, your employment will be managed directly through our approved agency provider.

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.