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Quality Assurance Operations Specialist
2 months ago
AmplifyBio is a leading contract research organization that provides a comprehensive range of services for the pharmaceutical and biotechnology industries. Our company is committed to growing and empowering an inclusive community within our organization and industry.
Job SummaryWe are seeking a highly experienced Quality Assurance Operations Specialist to join our team at AmplifyBio's Manufacturing Enablement Center in New Albany, OH. The ideal candidate will have a strong background in GMP regulation and guidelines, as well as experience in cell & gene therapy manufacturing.
Key Responsibilities- Review and approve GMP documentation, including SOPs, batch records, deviations, and investigations.
- Manage and trend lot/product disposition activities.
- Provide guidance on Quality topics to foster a quality culture and quality mindset.
- Investigate and resolve quality issues in a timely and effective manner.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
- Develop and implement quality metrics and analysis trends.
- Bachelor's degree or higher in a relevant scientific discipline.
- Minimum of 2/4/8+ years of experience in Quality and GxP biotechnology or pharmaceutical environment with supervisory responsibilities.
- Extensive cGMP quality system knowledge and experience.
- Experience using and managing eQMS, such as Veeva.
- Strong interpersonal skills, ability to work in a team environment, attention to detail, and excellent problem resolution skills.
- Competitive compensation package.
- Health, dental, and vision insurance.
- Flexible PTO policy.
- Generous paid parental leave.
- Wellness and self-care programs.
- 401(k) match.
- Tuition reimbursement.
- EAP/work-life support system.
At AmplifyBio, we value diversity and inclusion. We are committed to creating a workplace where everyone feels valued, respected, and empowered to contribute their best work. We believe in fostering a culture of innovation, collaboration, and continuous learning.
