Quality System Specialist - Temporary

Responsibilities

Identifying and digitizing physical records to transfer into the Bio-Rad eQMS and regulatory databases.

Coordinating and facilitating meetings with cross-functional stakeholders as necessary to gather information and data required for the completeness and accuracy of migrated documentation.

Supporting the migration of product design and technical records into the eQMS system, ensuring document metadata is accurate and files are correctly linked to legacy product DHF and IVDR Technical File binders in coordination with DHF migration efforts.

Assessing legacy design and technical documentation and identifying gaps relative to initial IVDR transitional activities versus new guidance documents and updates, as needed, to global quality management procedure requirements.

Supporting other IVDR-related technical documentation updates and gap assessments, including identification of legacy design and development documentation and migration into eQMS as necessary (document scanning, archiving, etc.).

Qualifications

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.

What You Bring

• Education: High school diploma or equivalent. Some college a plus.
• Work Experience: 0-1 years experience in a regulated manufacturing industry or equivalent combination of education and experience.
• Detail-oriented and ability to multitask.
• Basic understanding of GMP and quality system standards desirable.
• Proficient in Microsoft Office, Visio, Copilot. Experience with eQMS systems (EtQ, Veeva a plus).

Pay

The estimated hourly range for this position is $35 to $40 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.

Schedule

As a temporary associate, your employment will be managed directly through our approved agency provider.