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Senior Quality Assurance Specialist
2 months ago
Omni Inclusive is seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a key member of our Quality Assurance Operations department, you will play a critical role in ensuring the highest standards of quality and compliance in our manufacturing processes.
Key Responsibilities:- Lead and facilitate deviation triages, investigations, and CAPA records to ensure timely and effective resolution of quality issues.
- Partner with cross-functional teams to drive on-time phase completion and ensure compliance with regulatory requirements.
- Develop and maintain strong business partner relationships to ensure effective communication and collaboration.
- Utilize complex Root Cause Analysis (RCA) tools and methodologies to identify and implement process improvements.
- Provide quality support to Manufacturing personnel on the floor and provide guidance during GMP events and deviation investigations.
- Bachelor's degree in a relevant science or engineering discipline.
- 5-8 years of experience in oversight and execution of deviation initiation, investigations, and approvals within a quality management system.
- Experience in cGMPs and FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.
- Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
- Ability to analyze complex data and identify root causes of quality issues.
- A dynamic and collaborative work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
We are an equal opportunities employer and welcome applications from diverse candidates. If you are a motivated and experienced Quality Assurance professional looking for a new challenge, please submit your application.
