GxP Quality Systems & Document Control Lead

Bicara Therapeutics; Boston; Hybrid; PHP 5,518,087 - 7,357,449; Full time

Job summary

Bicara Therapeutics is hiring a Senior QA Specialist focused on GxP Document Control and Quality Systems, based in Boston with a hybrid schedule. This position is pivotal in supporting Quality Management System administration, ensuring compliance, and enhancing documentation practices.

The ideal candidate will have a scientific background, at least 5 years of Quality Assurance experience, and proficiency in Microsoft Excel and eQMS tools. This role includes working closely with other departments to ensure quality systems initiatives are successfully implemented.

Qualifications

• Minimum 5+ years of experience in Quality Assurance, Quality Systems, or Document Control.
• Experience within GxP-regulated environments.
• Strong proficiency in Microsoft Excel.

Responsibilities

• Lead document control activities within the electronic QMS.
• Maintain GxP documentation ensuring it’s inspection-ready.
• Support internal and external audit scheduling.

Skills

Quality Assurance

Document Control

GxP Regulatory Knowledge

Microsoft Excel

Analytical Skills

Organizational Skills

Communication Skills

Education

Bachelor’s degree in a scientific discipline

Tools

Smartsheet

Electronic Quality Management Systems (eQMS)

Job description

Bicara Therapeutics is hiring a Senior QA Specialist focused on GxP Document Control and Quality Systems, based in Boston with a hybrid schedule. This position is pivotal in supporting Quality Management System administration, ensuring compliance, and enhancing documentation practices.

The ideal candidate will have a scientific background, at least 5 years of Quality Assurance experience, and proficiency in Microsoft Excel and eQMS tools. This role includes working closely with other departments to ensure quality systems initiatives are successfully implemented.