Quality Assurance Inspector

Description

Title: Insurance Quality Assurance Inspector I (but actual role is QA Batch Record Reviewer).

Type: Entry-level QA position.

Location: On the manufacturing floor (in suites).

Function: Real-time batch record review and GMP walkthroughs.

Core Responsibilities

• Perform real-time batch record review during manufacturing.
• Conduct GMP compliance walkthroughs in production suites.
• Collaborate with operators and multiple teams to ensure compliance.
• Support QA activities on the floor, not just desk-based review. 

Must-Haves

• Education: Bachelor’s degree in a science field (Biology or Chemistry preferred, but flexible).

Experience:

• 0–2 years acceptable (entry-level).
• Prior experience with batch record review is a strong plus.
• GMP experience is critical (must have).
• Ability to work collaboratively with diverse teams and personalities.
• Strong communication skills and adherence to company values. 

Nice-to-Haves 

• Previous QA experience in a manufacturing environment.
• Familiarity with pharmaceutical or biotech operations. 

Soft Skills

• Collaborative and adaptable.
• Comfortable interacting face-to-face with operators.
• Strong attention to detail and compliance mindset.

Summary:

• The main function of a Quality Assurance Inspector is to ensure that products, materials, and processes meet established quality standards and regulatory requirements.
• A typical Quality Assurance Inspector performs batch record reviews, and collaborates with production teams to maintain consistent product quality.

Job Responsibilities:

• Conduct batch record review, document review and perform QA on the floor responsibilities.
• Collaborate with production and engineering teams to resolve quality issues.
• Ensure compliance with internal procedures and external standards (e.g., ISO, FDA). Participate in audits and support continuous improvement initiatives

Skills:

• Strong attention to detail and analytical thinking.
• Knowledge of quality assurance methodologies and regulatory standards Effective communication and documentation skills.
• Ability to interpret technical drawings and specifications. Familiarity with quality management systems and software.
• Ability to gown in and out of manufacturing suites is required.

Education/Experience:

• Bachelor's degree in a scientific field preferred
• 0-2 years of experience in quality assurance or inspection roles