Quality Assurance Analyst

Description
Our client, a well-established manufacturer/distributor in the life sciences industry seeks a QA Associate due to growth!

Responsibilities of the successful QA associate will include:

Conducting and overseeing annual product reviews in compliance with industry standards and company policies.
Managing documentation related to quality assurance processes, ensuring accuracy and completeness.
Implementing and maintaining metrics for quality system management.
Performing internal and external quality audits to ensure adherence to established protocols.
Demonstrating a comprehensive understanding of ISO 9001/13485 standards and ensuring their implementation.
Applying knowledge of ICH guidelines related to prescription drugs, nutritional supplements, cosmetic products, and medical devices.
Collaborating cross-functionally with various teams to ensure quality standards are met throughout the manufacturing process.
Contributing to continuous improvement initiatives aimed at enhancing quality systems and processes.
Remaining updated on industry regulations and best practices to ensure compliance.

Requirements
Experience Requirements:

Minimum of 3+ years of Quality Assurance (QA) experience in the life science manufacturing industry.
Familiarity with annual product reviews, documentation, and metrics for quality system management.
Conducting internal and external quality audits.
Strong understanding of ISO 9001/13485 standards.
Knowledge of ICH guidelines pertaining to pharmaceutical products.
Education:

A 4-year degree in Life Sciences or Business is required.

Preferred Skills:
Strong communication and interpersonal skills.
Detail-oriented with excellent analytical abilities.
Ability to work effectively in a team environment.
Proficiency in relevant software tools used in quality assurance and documentation management.

Quality Assurance
QA Management
QA Testing
ISO 13485
ISO 9001