QA Specialist, Environmental Monitoring
Intarcia Therapeutics, Inc., is a rapidly emerging biopharmaceutical company committed to developing innovative therapies that merge medicine with technology.
At Intarcia, we seek to transform the standard of care and improve patient outcomes in major therapeutic categories for serious chronic diseases, such as diabetes. We successfully completed our Phase 3 clinical trial program for our lead product, ITCA 650, and submitted our New Drug Application filing in the U.S. in 2016.
Additionally, we are developing a pipeline of products for our proprietary Medici Drug Delivery System™, comprised of three unique technologies: 1) A stabilization technology that allows for proteins, peptides, antibody fragments, and other highly potent small molecules to be stabilized at or above human body temperatures for up to three years or more; 2) A matchstick-sized osmotic mini-pump that is placed just under the dermal layer of skin to deliver a continuous and consistent flow of medication; and 3) A placement technology including proprietary tools designed to provide an optimal user experience.
We Are Growing
Since our 2012 round of financing, much progress has taken place at Intarcia, including significant enhancements to our world-class manufacturing facility, the opening of our new headquarters in Boston’s Innovation Center, and the diversification of expertise on our Board of Directors and Leadership Team through new senior leaders who contribute vital new capabilities and experiences.
A key element of pride during our progress has been our ability to remain fully independent throughout our rounds of financing so that we continue to have full strategic and executional control over all aspects of our rapidly evolving business. While we are always accountable to our stakeholders, we are – and intend to remain – the driving vision and force behind our progress and our ultimate success.
As a key member of the Quality Assurance team, the QA Specialist, Environmental Monitoring is responsible for performing QA data review for the Environmental Monitoring department. Working independently and under minimal supervision, the individual will be working in quality operations providing quality assurance support to the Environmental Monitoring department systems. In addition to EM test record review, this role will be responsible for tracking and verification of the data entry for the Quarterly and Monthly EM Trend Report, and creating graphical data for test results. The individual will be interacting with cross-functional groups such as Manufacturing, Document Control and our Contract laboratory.
Duties and Responsibilities:
• Perform a wide variety of quality assurance activities to ensure compliance with Company procedures and Quality System.
• Track and review all EM test records.
• Track and investigate EM excursions and associated deviations.
• Input and Review data for the EM Quarterly Trend reports.
• Track and prepare Monthly EM Excursion Reports.
• File, organize and track completed test records.
• Review documents such as standard operating procedures, logbooks, and temperature charts.
• Support continuous improvement of quality operations processes by revising existing department procedures and/or forms, and authoring new departmental procedures.
• Provide inspection readiness support and assist during inspections by regulatory authorities.
• May support quality systems as needed (e.g., issue and track closure to change controls).
• 4 - 6 years of experience in the pharmaceutical or biotechnology industry with at least 4 of those years in QA performing data review.
• Good working knowledge of 21 CFR Parts 201, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents.
• BS or equivalent in biology, chemistry or related science or equivalent experience.
• Good interpersonal and verbal and written communication skills.
• Ability to manage multiple projects.
• Good working knowledge and understanding of US and international (e.g. EU, ICH) cGMP regulations, procedures and guidelines that govern manufacturing, quality control and quality assurance of drugs/device.
• Attention to detail with an ability to perform critical review of various types of technical documents
• Proficient with commonly used word processing, database systems and other software.