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Eden Prairie

    QA Specialist II, GMP Manufacturing - Eden Prairie, United States - United Therapeutics

    United Therapeutics
    United Therapeutics Eden Prairie, United States

    3 weeks ago

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    Description
    California, US residents click here.

    The job details are as follows:

    What We DoWe 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.

    With over 100,000 patients on the organ transplant waitlist and only a fraction receiving the lifesaving organ they require, there is a great need for additional sources of transplantable organs.

    At Miromatrix, a leader in regenerative medicine and a subsidiary of United Therapeutics Corporation, we are working to address this unmet need by bioengineering human organs to help save and improve patients' lives.

    Join our team as we continue to make history by developing life-saving therapies to help patients with liver and kidney disease.

    How you'll contributeThe Quality Assurance Specialist II ensures that all intermediates and products manufactured at the Miromatrix are manufactured in accordance with current Good Manufacturing Practices (GMP) and meet all internal specifications.

    This position will support the manufacturing floor.

    This position is responsible for reviewing documents to ensure that they were completed in accordance with current GMP and site SOPs.


    Manufacturing Floor Support:

    Provide routine, real-time floor support to manufacturing teams, ensuring adherence to GMPs (GDPs) and established internal documentation including SOPs, Master Batch Records (MBRs), and Test Methods (TMs).

    Reports errors in a timely and appropriate manner.


    Batch Record Review:
    Perform batch record review in a timely manner to support clinical product availability.

    Work with operators and technicians to correct deficienciesMaterial Disposition:
    Disposition raw materials, starting materials, and intermediatesDeviations &


    CAPA:
    Work with Manufacturing to investigate and resolve product deviations. Support QA manufacturing deviations and CAPAs.


    CofC / CofA:
    Create Certificates of Analysis and/or Certificates of Conformance

    Manufacturing Documentation:
    Perform peer-review and contribute to the content of manufacturing related documentation including SOPs, Work Instructions (WIs), MBRs, Specifications and TMs

    Quality Metrics:

    Support QA manufacturing metricsSOPs: Author and revise Quality-related SOPs in eDMSDevelop effective working relationships with functional area peers and managersFor this role you will need Minimum RequirementsBachelor's Degree in life sciences (chemistry, pharmacy, biology, microbiology, engineering) or other technical/ scientific area preferred2+ years of experience in an FDA regulated industry, preferably in biotech or pharma1+ years of experience in a similar Quality roleWorking knowledge of current Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs)Experience supporting deviation investigationsAbility to recognize deviations and suggest resolutionsStrong attention to detail, strong time management and organizational skills, ability to adapt to changing business needsExcellent interpersonal skills, and ability to communicate effectively and collaborate cross-functionallyExcellent technical writing skillsPreferred QualificationsWorking knowledge of 21CFR 210 & 211At 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
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