Quality Assurance of Quality Control Associate Job at Imvax, Inc.
Imvax™ is a clinical-stage biotechnology company focused on the development of novel patient-specific immunotherapy strategies for the treatment of malignant gliomas and other cancers with unmet medical needs. It was launched as a stand-alone company in December 2015, to accelerate research and development of its glioblastoma treatment and opened a state-of-the-art headquarters and research facility in Philadelphia in early 2020. The company is accelerating the development of IGV-001 and has initiated a Phase 2b study in newly diagnosed glioblastoma (ndGBM).
IGV-001 is a first-in-class autologous cell therapy in development for the treatment of ndGBM. Based on early clinical research, one treatment with IGV-001 has the potential to trigger a multi-pronged immune response, including a short-term innate immune response followed by longer-term powerful adaptive immune activity that is selectively directed at tumor cells. A combination product, IGV-001 has been granted orphan drug designation by the FDA.
IGV-001 is a first-in-class autologous cell therapy in development for the treatment of ndGBM. Based on early clinical research, one treatment with IGV-001 has the potential to trigger a multi-pronged immune response, including a short-term innate immune response followed by longer-term powerful adaptive immune activity that is selectively directed at tumor cells. A combination product, IGV-001 has been granted orphan drug designation by the FDA.
Position Overview
Imvax is seeking a highly motivated individual for the role of Quality Assurance of Quality Control (QA/QC) Associate to work in this exciting new area of cancer immunotherapy. The QA/QC Associate will be responsible for performing quality-related tasks to assure compliance with regulations and standards set forth by regulatory and accrediting agencies for the pharmaceutical and diagnostic divisions of the company. The QA/QC Associate will support a broad range of quality/compliance activities associated with Quality Control Laboratories (Analytical and Microbiology). This role will be responsible for reviewing QC laboratory data, and conducting investigation for Out of Trend and Out of Specification test results. The QA/QC Associate will report to the QA/QC Lead.
Key Responsibilities
- Review and approve QC Analytical and Microbiology Laboratory data such as Endotoxin, Flow Cytometer, UPLC, ELISA, and Gram Stain
- Review and approve documents related to QC such as SOPs, Protocols, Test Methods, and Specifications
- Supports the Audit Program for both internal and external audit activities to ensure compliance to written procedures and regulatory requirements
- Review and approve Deviation, OOS/OOT, CAPAs, and Change Controls including support for interdepartmental personnel
- Track and trend Environmental Monitoring data and provide reports to management for evaluation
- Supports Supply Chain and Logistics department for dispositioning of released materials and providing input for material issues
- Supports the Instrument Qualification Program by reviewing executed qualification protocols or calibration certificates, as needed
- Provides quality support for the supplier qualification programs
- Establishes effective partnerships with internal staff to facilitate the timely identification and resolution of compliance and quality matters and other opportunities for quality process improvement
- Provides support to quality management in the preparation for, conduct of, and follow-up activities associated with site visits from clients and regulatory/accrediting agencies
- May participate in or facilitate organizational project teams
- Perform other quality or compliance related duties, as assigned
Professional Requirements
- BS in a scientific field
- 3-5 years related experience
- Knowledge and understanding of Quality assurance and Quality Control in laboratory environment, as well as laboratory controls and safety
- Experience working in an FDA regulated environment with cGMP’s pertaining to Biopharmaceutical products strongly preferred
- Computer skills competency including Excel, Word and PowerPoint programs
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and governmental regulations
- Ability to write reports, business correspondence, and procedure manuals
- Ability to effectively present information and respond to questions from staff and groups of managers
- Ability to develop and maintain effective working relationships at all levels of management
- Ability to solve practical problems and deal with a variety of concrete variables in situations where general standardization exists
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
- Ability to understand and comply with all applicable laboratory regulated guidelines
Attributes
- Ability to thrive in a fast-paced, entrepreneurial environment with busy, high-performing colleagues
- Ability to function at a high level in a team setting, adapting to changing environment as needed
- Positive management approach: ability to build strong relationships regardless of their background and expertise
- Strong leadership skills
- Recognized by former colleagues, customers, manager and/or direct reports for attributes congruent with Imvax values
- Excitement about the vision and mission of Imvax
Key Competencies
- Analytical Thinking: Ability to comprehend a situation by breaking it down into its components and identifying key or underlying complex issues. Systematically organizes and compares the various aspects of a problem or situation and determines cause-and-effect relationships and able to define and summarize actionable recommendations
- Patient Focused: Dedication to enabling translation of preclinical research into impactful human therapies
- Communication skills: Ability to understand the audience needs across all forms of communication (phone, in-person, email and documents) and to convey the information concisely and in an engaging manner
- Self-motivated: To initiate strategic independent and collaborative work assignment(s); raises hand to assist coworkers proactively
- Flexibility: Able to reprioritize as competing interests arise and to operate successfully in an environment with a developing structure
- Accountability: Strong commitment to ensure quality and timely deliverables while maintaining and building relationships with coworkers, managers, vendors, and clients
Our Values
- Collaboration: The working practice for a common purpose to achieve business purposed and benefit
- Innovation: A new method, idea, product, etc.
- Patient Centered: Respectful of, and responsive to, individual patient preferences, needs and values, and ensuring that patient values guide all clinical decisions
At Imvax we pride ourselves on being a patient centered, collaborative and innovative Clinical-stage Biotech company developing cancer immunotherapy treatment through our proprietary platform. With a brand-new purpose-built laboratory space located in the company’s headquarters at the Curtis Center in central Philadelphia, PA and a recently completed round of fundraising that resulting in an additional $112 million dollars, Imvax is poised for growth and is excited about the possibility of you joining our team. At Imvax, you will find an exciting scientific environment with industrial and academic partners, opportunity to present findings, as well as a competitive remuneration and incentive package.
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