Senior Quality Assurance Specialist
2 weeks ago
About the Role:
We are seeking a highly skilled Senior QA Associate to join our Site Inspections and Compliance team at Evolve Scientific. As a Senior QA Associate, you will be responsible for providing support for the preparation and execution of Self-Inspection to verify compliance with global GMP regulations and corporate requirements.
Key Responsibilities:
- Provide support for the preparation and execution of Self-Inspection to verify compliance with global GMP regulations and corporate requirements
- Identification and assessment of risks and facilitate appropriate mitigations to ensure compliance and continuous improvement
- Participate and support regulatory inspections at Seqirus, including providing responses to regulatory authorities in a timely manner
- Maintain processes, procedures, and SOPs for auditing and inspections to improve audit readiness
- Work with global colleagues to support the harmonization, maintenance and application of global audit strategy, processes, and SOPs
- Stay up to date with industry and regulatory trends to ensure compliance and continuous improvement
- Participate in local Quality Management Review and KPI preparation
Requirements:
- Tertiary education in a scientific discipline
- Previous quality/manufacturing experience in a similar role in the biotechnology or pharmaceutical industry
- Experience as an auditor in internal and external audits
- Knowledge and experience in sterile product manufacturing, biological processes, and laboratory operations (preferred)
- Knowledge of global cGMP regulations and ISO standards
- Excellent written and oral communication skills
- Ability to understand data sets and drive data-based decisions
- Excellent problem-solving skills and time management
What We Offer:
At Evolve Scientific, we offer a dynamic and supportive work environment, with opportunities for professional growth and development. We are committed to providing our employees with the tools and resources they need to succeed in their roles.
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