Senior Quality Assurance Specialist
4 days ago
Humacyte Global, Inc. is a leading biotechnology company developing innovative solutions for tissue repair and replacement. We are seeking a highly skilled Senior Quality Assurance Specialist to join our Quality Assurance Team.
Key Responsibilities:- Design and implement comprehensive Product Technical Complaints (PTC) and Investigations programs to ensure compliance with regulatory requirements.
- Develop and maintain standardized processes and procedures for complaint handling and investigation activities.
- Lead Investigations to identify root causes and contributing factors, and implement corrective and preventative actions (CAPAs) to prevent recurrence.
- Collaborate with cross-functional teams to address complaints and drive continuous improvement.
- Provide training and support to internal stakeholders on complaint handling procedures, documentation requirements, root cause analysis, CAPAs, and quality expectations.
- Minimum 10 years' experience working in a cGMP regulated facility in Quality Assurance with specific experience with Pharmaceutical Product Technical Complaints (PTCs) and Investigations.
- Strong understanding of FDA regulations and cGMP guidelines.
- Excellent analytical and critical thinking skills, with the ability to assess the severity and potential impact of quality events.
- Detail-oriented mindset with a commitment to maintaining accuracy and compliance in all aspects of investigations and reporting activities.
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- Collaborative and dynamic work environment.
Humacyte Global, Inc. is an equal opportunities employer and welcomes applications from diverse candidates. Please submit your application, including your resume and a cover letter, to [insert contact information].
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