Quality Assurance Specialist: ISO 13485 & Change Control

Automatic Data Processing, Inc.; San Diego (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

Automatic Data Processing, Inc. seeks a Quality Specialist II to support the implementation and maintenance of the QMS in line with ISO 13485 and regulatory requirements. The role covers batch record review, incoming inspection, and document control to ensure product quality.

Responsibilities include managing change control, material specifications, and quality records, while driving continuous improvement and cross-functional collaboration within a growing biotech manufacturing environment.

Qualifications

• Experience with document control, change control, and batch records.
• Knowledge of ISO 13485, GDP, and IVDR regulations.
• Strong attention to detail and cross-functional collaboration.

Responsibilities

• Own document and change control processes including creation, review, approval, and release.
• Review and approve receiving material specifications and manufacturing batch records.
• Maintain quality and manufacturing records and resolve discrepancies.
• Manage controlled identification numbers for quality documents and records.
• Support employee onboarding by coordinating training and records.
• Prepare and issue Certificates of Analysis (CoAs) per specs.
• Perform additional duties to support quality operations and improvement.

Skills

Document control

Change control

Batch records

Material specs

Quality records

ISO 13485

GDP

IVDR

MS Office

Attention to detail

Cross-functional teamwork

Communication skills

Education

Bachelor's degree in Life Sciences

GMP experience

QA/QMS experience

Tools

MS Office

Job description

Automatic Data Processing, Inc. seeks a Quality Specialist II to support the implementation and maintenance of the QMS in line with ISO 13485 and regulatory requirements. The role covers batch record review, incoming inspection, and document control to ensure product quality.

Responsibilities include managing change control, material specifications, and quality records, while driving continuous improvement and cross-functional collaboration within a growing biotech manufacturing environment.