
Lead QA Specialist
2 days ago
Job Title: Quality Assurance Professional
We are seeking a skilled Quality Assurance (QA) Specialist to support our rapidly evolving laboratory operations. This is a pivotal role for someone who is passionate about quality, thrives in a fast-paced environment, and is ready to hit the ground running as we establish in-house QA capabilities.
As we set up our lab infrastructure and transition analytical methods internally, the successful candidate will play a key role in ensuring the reliability and consistency of our testing practices. You'll collaborate cross-functionally and work closely with technical, operations, and quality teams to build our QA capabilities from the ground up.
Key Responsibilities:
- Assist with the setup and operationalisation of the new QA laboratory.
- Lead or support the transfer, validation, and qualification of analytical methods for internal use.
- Implement robust procedures for method documentation and compliance.
Finished Product Testing:
- Execute and document final product testing to support batch release.
- Investigate any out-of-specification results or quality deviations in coordination with the quality team.
Documentation & Compliance:
- Maintain high standards of GMP documentation and record-keeping.
- Support the development of Standard Operating Procedures (SOPs), forms, and test records.
- Assist with audits, internal inspections, and continuous improvement initiatives.
Position Requirements:
- Prior hands-on experience in a Quality Control or Assurance role within a pharmaceutical, biotechnology, or related laboratory environment.
- Strong knowledge of laboratory instrumentation and analytical techniques relevant to raw material and finished product testing.
- Experience with method transfers and laboratory setup is highly desirable.
- Understanding of GMP/GLP and regulatory expectations related to QA.
- Excellent attention to detail, organisation, and problem-solving skills.
- Ability to work autonomously and adapt to a fast-moving, start-up style environment.
The ideal candidate will have a passion for quality, a strong technical background, and excellent communication skills. They will be able to work effectively in a team environment and adapt to changing priorities and deadlines.
Why Join Us?
- Opportunity to make a tangible impact by shaping our internal QA capability from day one.
- Dynamic and collaborative team culture.
- Exposure to diverse projects and cutting-edge product development.
- Flexibility and autonomy in your working style.
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