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Investigation Specialist
2 months ago
The QA Investigation Specialist is a key player in ensuring the quality and safety of pharmaceutical products. As a member of the Quality Assurance team, this role is responsible for conducting thorough investigations into non-conformities, deviations, and complaints related to pharmaceutical manufacturing processes.
Responsibilities:
- Conduct root cause investigations into non-conformities and deviations, identifying and mitigating risks to patient safety and product quality.
- Evaluate and analyze data to determine the root cause of issues, and develop corrective and preventive actions to prevent recurrence.
- Collaborate with cross-functional teams to implement corrective actions and ensure compliance with regulatory requirements.
- Develop and maintain investigation databases and reports, providing insights into trends and areas for improvement.
- Stay up-to-date with regulatory requirements and industry best practices, ensuring that investigations are conducted in accordance with established procedures.
Requirements:
- Strong analytical and problem-solving skills, with the ability to summarize complex data and develop effective solutions.
- Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams and stakeholders.
- Technical writing skills, with the ability to develop clear and concise investigation reports and summaries.
- Ability to work in a fast-paced environment, with multiple priorities and deadlines.
What We Offer:
- A dynamic and collaborative work environment, with opportunities for professional growth and development.
- A competitive salary and benefits package, including health and dental insurance, retirement savings plan, and paid time off.
- The opportunity to work with a leading pharmaceutical company, contributing to the development and delivery of high-quality products that improve patient outcomes.
