Quality Assurance
1 day ago
Job Title: QA Validation Specialist
We are seeking a skilled QA Validation Specialist to join our client on a contract basis and play a key role in ensuring site-wide validation and regulatory compliance.
About the Role:
As a QA Validation Specialist, you will coordinate and maintain the site validation program, ensuring compliance with FDA, European cGMP, and GAMP standards. This is a hands-on role that involves planning and executing validation activities, managing quality processes, and driving continuous improvement initiatives across equipment, utilities, processes, and software systems.
Key Responsibilities:
- Develop, execute, and maintain Validation Master Plans and Project Validation Plans.
- Prepare and execute validation protocols, reports, and investigations to cGMP standards.
- Lead validation and quality assurance for site equipment, processes, and software.
- Support regulatory compliance through robust documentation, audits, and process improvements.
- Manage change control, exception events, and corrective actions.
- Provide cross-training, mentorship, and support to team members.
- Actively contribute to continuous improvement in manufacturing, quality, and safety systems.
Requirements:
- Degree in an engineering or scientific discipline.
- 3+ years' experience in validation/quality within medical device plastics processing, molding, or assembly operations.
- Strong knowledge of cGMP and medical device regulatory requirements.
- Excellent communication, organizational, and troubleshooting skills.
- Ability to work independently and as part of a team, with strong prioritization and multitasking skills.
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