This company is a pioneer in the cGMP production sector and is committed to developing gene therapy. Their goal is to create novel, secure, and efficient long-term treatments for illnesses by utilizing their expertise, resources, technology, and knowledge in the fields of translational and regulatory science. As they work to make a difference with every product and instill hope in the hearts of every patient and their family, there is no condition too uncommon or difficulty too great. The main idea of this biotech company is the full-service production of Adeno Associated Viruses (AAV).
Qualifications:
- Working knowledge of team function within the organization
- Excellent detailed knowledge of cGMP, GLP, FDA guidelines
- Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change
- Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting
- Ability to work independently as well as collaboratively in a diverse and inclusive work environment
- Must possess a client-focused mindset in daily tasks
Responsibilities
- The QA Operations Supervisor role is responsible for supporting internal Quality Assurance functions focused on GMP manufacturing operations and associated Quality systems, including change controls and internal process verification
- The supervisor will work collaboratively with the training team to ensure manufacturing colleagues are operating in compliance with Quality systems
- Execute Quality systems to support CDMO manufacturing and lot release, GxP auditing, and training
- Provides quality support for external and internal AAV and Plasmid manufacturing and clinical product distribution
- Review and audit complex documents: batch records, GMP protocols, and process and method validations
- Fully support the Product Disposition of client AAV and Plasmid lots for release
- Review and approve master and executed batch records
- Observe manufacturing activities to support the implementation of best practices and improvements
- Administer, review, follow-up, and approve internal/external Deviations, Change Records, and Corrective and Preventive Actions (CAPAs)
- Manage the DMS by authoring, reviewing, and approving Policies, SOPs, and WINs as needed
- Communicate quality metrics, client production tracking and metrics, and quality improvement initiatives to senior leadership
- Provide oversight and input to Trend Review Reporting and Lifecycle Review activities to identify and address process shifts and trends
- Act as QA SME during client and regulatory audits
- Schedule QA-on-the-floor responsibilities for the QA Operations team in support of manufacturing activities
- Ensures that documentation is maintained in accordance with internal procedures and regulatory requirements
- Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments
- Exercise discretion, judgment, and personal responsibility
Benefits
- The opportunity to work alongside experts who have over 10 years in the gene therapy field
- Competitive compensation
- Eligible on day one for medical, dental, and vision insurance plans with basic vision at 100% company-paid
- 160 hours of Paid Time Off annually
- 11 Company Paid Holidays plus 2 floating holidays annually
- Company Paid Life Insurance
- 401(k) Match
- Company Paid short and long-term disability
- 4 weeks of Paid Parental Leave for birth and adoption
- Adoption Assistance
- Tuition Reimbursement and Student Loan Repayment Assistance
- Company Paid LinkedIn Learning access
- Employee Assistance Programs
- Flexible work options (role specific)
