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Senior Quality Assurance Specialist
3 weeks ago
Indivior PLC is seeking a highly experienced Quality Assurance professional to join our team in North America. As a Senior Quality Assurance Specialist, you will play a critical role in ensuring that our products meet the highest standards of quality and regulatory compliance.
This is a fantastic opportunity for someone with a strong background in GMPs and regulatory requirements to lead and manage the activities of the Operational Quality Section within the North American region.
The successful candidate will have a proven track record of experience in finished product dispositioning, reviewing manufacturing and packaging batch records, and analytical testing results. They will also possess excellent leadership, communication, and problem-solving skills, as well as a strong understanding of current GMPs and regulatory requirements related to international standards.
If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.
About the Team:
You will be part of a dynamic and supportive team that is dedicated to delivering high-quality products to our customers. Our team is committed to maintaining a workplace where employees feel comfortable raising concerns about potential violations of policies or unethical behavior.
We offer a comprehensive benefits package, including health insurance, 401(k) matching, and employee stock purchase plan. Additionally, you will have access to ongoing training and development opportunities to help you grow your career with Indivior.
Responsibilities:
The Senior Quality Assurance Specialist will be responsible for:
- Evaluating and implementing changes to ensure continued compliance with regulatory requirements.
- Leading internal audits and remediation efforts to address any findings.
- Maintaining inspection readiness and supporting management during inspections by competent authorities.
- Developing and implementing effective corrective actions to address deviations and other quality issues.
Requirements:
To be successful in this role, you will need to have:
- A Bachelor's degree in a relevant scientific discipline.
- At least 10 years of experience in a regulated industry, such as FDA, pharmaceutical, or medical device.
- Proven track record of leading and managing quality teams.
- Excellent communication and interpersonal skills.
- Ability to analyze complex data and develop effective solutions.
