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California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .

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 Assurance Engineer II, Device will support the development of new and maintenance of the sustaining and combination products through the design and development, implementation, commercialization and maintenance, and improvement of currently marketed products. Responsible for implementation of standards, methods and procedures for investigation and evaluation of product development process.

• Perform quality engineering (QE) role for commercial and new products in all stages of design control activities, ensuring compliance to quality systems procedures, regulations, and standards

• Provide quality assurance (QA) input to process and manufacturing documentation, including but not limited to, material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested

• Collaborate on investigations for quality events, deviations, investigations, out of specifications (OOS), change controls, exceptional conditions, and corrective and preventive action (CAPA) processes for cGMP events

• Contribute to QA methodologies supporting engineering, manufacturing, and regulatory functions

• Provide oversight to CMO-related manufacturing processes, change controls, investigations, and new projects

• Provide support to QE management during regulatory agency inspections (FDA, MHRA, etc.) and participate in the closure of internal and regulatory audit observations

• Support risk management activities, FMEA(s), and ensure compliance to standards and regulations

• Support the development of product Design History Files (DHF), Technical Files, and Device Master Records (DMR)

• Support device acceptance and release activities, and contribute to Quarterly Quality Business reviews with Contract Manufacturers (CMOs)

• Present technical information on projects or areas of expertise

• Support SME in change management activities and intra-departmental relationship building

• Support maintenance of Quality Agreements with suppliers and CMOs

• 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

• Performs other responsibilities and duties as assigned

For this role you will need

Minimum Requirements

• Bachelor’s Degree in engineering, science, or related field

• 3+ years of experience in quality assurance, quality engineering in the FDA regulated environment (or related industry) with Bachelor’s degree

• Must have a clear understanding and application of QA and cGMP principles, concepts, industry practices, and standards

• Demonstrate expertise with FDA Quality System regulations and cGMP, ISO 13485:2003, ISO 14971, ISO 10993, IEC 60601, and IEC 62304

• Working knowledge of Design Controls, Product Development Processes

• Strong computer skills and demonstrated competence to include MS Office applications, database applications, and spreadsheets

• Ability to define problems, collect data, establish facts, and draw valid conclusions

• Strong attention to detail and organizational skills

• Strong verbal and written communication skills

• Strong interpersonal skills and ability to work as an effective team member

• Able to work independently with occasional need for guidance

Preferred Qualifications

• Master’s Degree in engineering, science, or related field

• 1+ years of experience in quality assurance, quality engineering in the FDA regulated environment (or related industry) with Master’s degree

• 1+ years of experience with combination products or medical devices in a FDA regulated environment

• Familiar with Human Factors testing

• Knowledge of Laboratory Information Management System (LIMS), Systems Application and Product (SAP), MasterControl, MiniTab, Trackwise and Empower software systems

• Working knowledge of statistics, data interpretation/presentation, engineering experiments/design of experiments (DoE)

• Experience with biocompatibility, extractable/ leachable, and sterility testing/processes

• Experience in process development activities for manufacturing/ assembly operations

• Experience with common lab test instrumentation and equipment, design of jigs, fixtures, process equipment, and software

• Previous experience in regulatory inspections

• Electronics aptitude, including the ability to read schematics, wiring diagrams, etc.

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.

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.