Quality Assurance Specialist 3
NextCure is a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases by restoring normal immune function. We view the immune system holistically and, rather than target one specific immune cell type, we focus on understanding biological pathways, the interactions of cells and the role each interaction plays in an immune response. We are focused on patients who do not respond to current therapies, patients whose cancer progresses despite treatment and patients with cancer types not adequately addressed by available therapies.
We develop products from gene cloning to final drug product focusing on production efficiency and ease of technology transfer and process operations. This “All Stream” approach integrates all aspects of development with the highest level of quality and is designed to improve outcomes by eliminating the traditional “silos” between cell line development, cell culture process development, downstream process development, formulation, analytical chemistry, and product characterization.
NextCure’s dedicated, state-of-the-art GMP manufacturing facility supports our biologics pipeline and candidates advancing into clinical development. The cleanroom space features state-of-the-art construction materials and utilizes single-use production systems. The clinical production space is designed to operate as a multi-product facility to support NextCure’s robust pipeline of first-in-class immunotherapy-based product candidates.
We are seeking a highly motivated QA Specialist 3. The candidate must thrive and adapt to a fast-paced, innovative and changing environment
- Interpret and implements quality procedures
- Assist in facilitating regulatory compliance inspections
- Act as QA reviewer for audit, investigations, deviations, SOPs, batch records, and corrective and preventive action plans (“CAPA”) and change controls
- Review documents to ensure protocol requirements are followed
- Write, revise, and approve GMP documentation as necessary
- Review of validation protocols/reports, technical reports, etc.
- Effectively utilize Operational Excellence tools such as FMEA, DMAIC and root cause analysis.
- Investigate and assess the impact of minor and major deviations that may occur during manufacture, testing or distribution of products or during the administration of quality systems.
- Identify root cause, recommend, and implement corrective actions to prevent recurrence.
- Participate and facilitate risk assessment teams as needed
- Ensure that QMS systems are in a compliance state and support continuous improvement.
- Provide support to supplier/vendor qualification; conduct and enforce audit best practices.
- Create and align supplier procedures with purchasing/procurement.
Required education and experience
- Minimum of a B.S. in a Life Sciences discipline
- +5 years’ experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry
- +5 years’ experience in Quality Assurance/Quality Control function
- +5 years’ working within a GMP environment
- A strong understanding of the pharmaceutical/drug development process
- Knowledge and application of CGMP principles and working in FDA-regulated environment
- Previous experience working in Quality within large or small molecules, manufacturing, and lab assays
- Ability to work under pressure and analyze processes within scheduled timeframes
- Ability to work independently and in a team setting with minimal supervision
- Ability to make sound decisions regarding compliance-related issues with minimal supervision
- Excellent communication skills with an ability to manage stressful and confrontational situations and move them to positive outcomes
- In depth knowledge of FDA, GCP, ICH, and other state and federal agency guidelines for the conduct of clinical trials
- Good communication skills and strong attention to detail
NextCure is an Equal Opportunity Employer and offers a competitive salary, cross functional exposure and potential career growth in a scientifically engaged team work environment. Benefits package includes Medical, Dental, Vision, 20 days of paid time off annually + paid holidays and 401K; all offered from day one of employment.