Senior QA Specialist, GMP Manufacturing - United Therapeutics
Eden Prairie, MN
About the Job
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.
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 contribute
The Senior QA Specialist – GMP Manufacturing, is responsible for supporting quality operations during GMP clinical manufacturing of bioengineered organs at Miromatrix. The Senior QA Specialist collaborates with and provides support for end-to-end clinical manufacturing. This role is critical to ensuring finished product is manufactured to approved manufacturing batch records and processes.
+ 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. Coordinate completion of batch record review in a timely manner to support clinical product availability. Work with operators and technicians to correct deficiencies and mentor to assure understanding.
+ Material Disposition: Disposition raw materials, starting materials, intermediates and finished products
+ Deviations & CAPA: Work with Manufacturing to investigate and resolve product deviations. Propose corrective and preventive actions (CAPAs). Own respective QA manufacturing deviations and CAPAs.
+ Leadership: Coordinate with QA Manager and other staff members in organizing department workload
+ CofC / CofA: Review and approve Certificates of Analysis and/or Certificates of Conformance
+ SOPs: Author, revise and approve Quality-related SOPs in eDMS. Own Change Controls
+ Quality Metrics: Compile and analyze data with respect to QA manufacturing metrics
+ Manufacturing Documentation: Review and approve manufacturing related documentation including SOPs, Work Instructions (WIs), MBRs, Specifications and TMs
+ Quality Systems: Provide support to Quality Systems, as needed, related to OPO (Organ Procurement Organization) qualification and donor eligibility
+ Develop effective working relationships with functional area peers and managers
+ Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues in a timely manner
+ Continuously engage in activities to identify, assess, propose, and implement Quality process and system improvements, with focus on batch review and disposition processes
For this role you will need
Minimum Requirements
+ Bachelor’s Degree in life sciences (chemistry, pharmacy, biology, microbiology, engineering) or other technical/ scientific area preferred
+ 5+ years of experience in an FDA regulated industry, preferably in biotech or pharma.
+ 3+ years of experience in a similar Quality role
+ In-depth, working knowledge of current Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs)
+ Working knowledge of Deviations, Investigations, and Root Cause Analysis Tools. Ability to lead resolution to deviations.
+ Ability to prioritize and drive activities and adapt to changing business needs
+ Ability to build strong relationships cross-functionally to foster a collaborative approach across teams
+ Superb technical writing skills
Preferred Qualifications
+ Broad working knowledge of pharmaceutical and biotechnology regulations and industry standards
+ Working knowledge of cell therapy manufacturing and product release
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._
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.
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 contribute
The Senior QA Specialist – GMP Manufacturing, is responsible for supporting quality operations during GMP clinical manufacturing of bioengineered organs at Miromatrix. The Senior QA Specialist collaborates with and provides support for end-to-end clinical manufacturing. This role is critical to ensuring finished product is manufactured to approved manufacturing batch records and processes.
+ 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. Coordinate completion of batch record review in a timely manner to support clinical product availability. Work with operators and technicians to correct deficiencies and mentor to assure understanding.
+ Material Disposition: Disposition raw materials, starting materials, intermediates and finished products
+ Deviations & CAPA: Work with Manufacturing to investigate and resolve product deviations. Propose corrective and preventive actions (CAPAs). Own respective QA manufacturing deviations and CAPAs.
+ Leadership: Coordinate with QA Manager and other staff members in organizing department workload
+ CofC / CofA: Review and approve Certificates of Analysis and/or Certificates of Conformance
+ SOPs: Author, revise and approve Quality-related SOPs in eDMS. Own Change Controls
+ Quality Metrics: Compile and analyze data with respect to QA manufacturing metrics
+ Manufacturing Documentation: Review and approve manufacturing related documentation including SOPs, Work Instructions (WIs), MBRs, Specifications and TMs
+ Quality Systems: Provide support to Quality Systems, as needed, related to OPO (Organ Procurement Organization) qualification and donor eligibility
+ Develop effective working relationships with functional area peers and managers
+ Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues in a timely manner
+ Continuously engage in activities to identify, assess, propose, and implement Quality process and system improvements, with focus on batch review and disposition processes
For this role you will need
Minimum Requirements
+ Bachelor’s Degree in life sciences (chemistry, pharmacy, biology, microbiology, engineering) or other technical/ scientific area preferred
+ 5+ years of experience in an FDA regulated industry, preferably in biotech or pharma.
+ 3+ years of experience in a similar Quality role
+ In-depth, working knowledge of current Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs)
+ Working knowledge of Deviations, Investigations, and Root Cause Analysis Tools. Ability to lead resolution to deviations.
+ Ability to prioritize and drive activities and adapt to changing business needs
+ Ability to build strong relationships cross-functionally to foster a collaborative approach across teams
+ Superb technical writing skills
Preferred Qualifications
+ Broad working knowledge of pharmaceutical and biotechnology regulations and industry standards
+ Working knowledge of cell therapy manufacturing and product release
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._
Source : United Therapeutics