
Quality Assurance Specialist
2 weeks ago
We are seeking a skilled Quality Assurance professional to support our rapidly evolving laboratory operations.
This pivotal role is ideal for someone passionate about quality, thriving in a fast-paced environment, and ready to establish in-house QA capabilities.
The successful candidate will ensure the reliability and consistency of testing practices by collaborating with technical, operations, and QA teams to build our QA capabilities from the ground up.
Main Responsibilities:
- Assist with the setup and operationalization of the new laboratory.
- Lead or support the transfer, validation, and qualification of analytical methods for internal use.
- Implement procedures for method documentation and compliance.
- Perform quality testing of incoming raw materials.
- Conduct in-process quality assessments.
- Troubleshoot and refine QA workflows.
- Execute and document final product testing for batch release.
- Investigate out-of-specification results or deviations with QA.
- Maintain GMP documentation and records.
- Support SOP development, audits, inspections, and continuous improvement.
Requirements:
- Hands-on experience in a QA role within pharmaceutical, biotech, or related labs.
- Knowledge of laboratory instrumentation and analytical techniques.
- Experience with method transfers and lab setup is desirable.
- Understanding of GMP/GLP and regulatory standards.
- Attention to detail, organization, and problem-solving skills.
- Ability to work independently in a start-up environment.
About Us:
Our approach is simple: we put the client's interests first, we do not stop until it is right, and we will do whatever it takes to get there.
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