ISO / Quality Associate (Onsite)

Please note this is a 12-18 Month Contract Position and is ONSITE in Pacheco, CA.

Preferred Skills

• Product development experience within an IVD, biotechnology, or regulated laboratory environment.
• Familiarity with GMP requirements.
• Experience with technical documentation and document control.
• Ability to work cross-functionally with R&D, Manufacturing, QC, QA, and Marketing.
• Strong attention to detail and organizational skills.

Required Qualifications

• Bachelor’s degree in a scientific or technical field. (Manager will accept Associates as the least)
• 1–3 years of related R&D experience or training.
• Understanding of IVD development.
• Knowledge of Design Controls and Quality System Regulations.
• Familiarity with ISO 13485, IVDR, and MDSAP requirements.
• Strong verbal and written communication skills.
• Ability to effectively communicate and present complex information.

As an Associate Product Development Scientist, you will:

• Facilitate and support product development projects.
• Draft design outputs for review by Product Design management.
• Assist with technical document review, including test records, data sheets, product labeling, SOPs, and design-output documentation.
• Edit product data sheets and assist with revisions to departmental procedures.
• Revise documentation associated with product implementations and discontinuations.
• Participate in routine laboratory activities, including preparation of purchase requisitions and ordering laboratory supplies.
• Monitor new reagent products through the Product Development Life Cycle (PDLC) across R&D, Manufacturing, QC, QA, and Marketing.
• Identify potential obstacles affecting product development timelines and coordinate with cross-functional teams.
• Support GMP-compliant product development activities.
• Organize test results and assist with drafting, proofreading, scanning, and preparation of product-development documentation.
• Assist with oversight of antibody raw material inventory within R&D.

This is a full-time- contract opportunity.

Candidates must provide their phone number. Job reference number is A5578.