Quality Engineer II - Solid Dose

California, US residents click here. The job details are as follows: What We Do We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization. Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases. How you’ll contribute The Quality Engineer II will provide support to maintain cGMP compliance for UTC commercial products, clinical materials supply, and new product development of active pharmaceutical ingredients (API), drug substances, drug products, and combination product/medical devices. This role will support the implementation of process qualification and validation activities and commercialization including documentation review and process improvement of currently marketed products. Responsibilities for this role also include support of the Change Control, Quality Event, and CAPA programs, Vendor Management, and supporting management during regulatory agency(ies) inspections, third-party partners, and customer audits. Collaborate and approve GMP related documents (i.e. IOQ and PQ documents, process validation protocols, analytical/microbiological method validations, stability protocols, operational protocols and reports, etc.) pertaining to chemical intermediates APIs and drug products for accuracy, completeness, and compliance with UT policies, procedures, and cGMPs Collaborate on investigations for Quality Events, Investigations, Out of Specifications (OOS), Change Controls, and Corrective and Preventive Action (CAPA) processes for cGMP events Create or assist in the creation of Batch Records, Protocols, Summary Reports, Standard Operating Procedures, Raw Material Specifications, etc. Provide QA input to process and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing and packaging procedures, to ensure that the resulting products can be adequately manufactured and tested Participate in quality system project initiatives, project start-up, and continuous process verification Present technical information on projects or areas of expertise Support maintenance of Quality Agreements with suppliers and contract manufacturing organizations Provide support to QA management during regulatory agency and health authorities inspections (FDA, etc.) and participate in the closure of internal and regulatory audit observations Provide oversight to CMO related manufacturing processes, change controls, investigations, and new projects. Perform activities as needed to support operational processes critical to product quality Support SME in change management activities and intra-departmental relationship building All other duties as required For this role you will need Minimum Requirements Bachelor’s Degree in engineering, chemistry, biology, biochemistry, or related scientific discipline 3 years of relevant pharmaceutical industry experience in a cGMP environment 3 years of experience in quality assurance, quality engineering, or validation role A clear understanding and application of QA and cGMP principles, concepts, industry practices, and standards Ability to define problems, collect data, establish facts, and draw valid conclusions Strong organizational skills and strong attention to detail Strong verbal and written communication skills Strong interpersonal skills and ability to work as an effective team member Actively participate in process improvement Strong technical writing skills A working knowledge of US FDA, EU, and JP GMP regulations Must be proficient in Microsoft Excel, Word, PowerPoint and Adobe Acrobat Able to work independently and as part of a multi-functional team, being able to manage and prioritize workloads, stressful situations, and deadlines Preferred Qualifications 1 years of experience with solid dose drug manufacturing Experience with aseptic processing and media fill programs Knowledge of Laboratory Information Management System (LIMS), Systems Application and Product (SAP), MasterControl, MiniTab, Trackwise and Empower software systems Familiarity with pharmaceutical operations (i.e., aseptic filling, etc.), biologics operations, medical devices, and combination products Previous experience with validation and facility qualification Previous experience in regulatory inspections Process start up and clinical trial material manufacturing experience Experience performing technology and product transfers Continuous process verification Knowledge of software validation practices and data integrity initiatives At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients. United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success. We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.