Quality Assurance Associate - ISO 9001:2015 & GMP

KINOVATE LIFE SCIENCES, INC; Carlsbad (CA); On-site; USD 60,000 - 78,000; Full time

Job summary

KINOVATE Life Sciences, Inc. in Carlsbad, CA, seeks a Quality Assurance Associate to support QA policies and ISO 9001:2015 compliance, focusing on material inspection, batch record review, and QA documentation.

You will collaborate with cross-functional teams to ensure cGMP adherence, timely QA support for production activities, and proper line clearance for customer delivery. Ideal candidates hold a bachelor's degree in a scientific field with 1–2 years in a regulated manufacturing environment,

Qualifications

• Bachelor’s degree in a scientific field with 1–2 years in a regulated manufacturing environment.
• Familiarity with ISO 9001:2015 standards and cGMP concepts.
• Strong written and verbal communication, proficient in MS Office.

Responsibilities

• Inspects raw materials and packaging components; verifies labeling and records QA tests.
• Issues batch record documentation to Production and supports line clearance.
• Reviews raw material and finished product documentation for disposition.
• Assists with document change control, eDMS submissions, redlines, and approvals.
• Photocopies, scans, and archives QA and training records; maintains logs.

Skills

Quality assurance

cGMP knowledge

Documentation

Problem solving

Education

Bachelor’s degree in a scientific field

Job description

KINOVATE Life Sciences, Inc. in Carlsbad, CA, seeks a Quality Assurance Associate to support QA policies and ISO 9001:2015 compliance, focusing on material inspection, batch record review, and QA documentation.

You will collaborate with cross-functional teams to ensure cGMP adherence, timely QA support for production activities, and proper line clearance for customer delivery. Ideal candidates hold a bachelor's degree in a scientific field with 1–2 years in a regulated manufacturing environment,