Quality Assurance Specialist
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.
How you'll contributeThe Quality Assurance Specialist is responsible for maintaining cGxP quality systems in all operational phases associated with genetically engineered (GE) pigs.
Facilitates and assists the company's quality assurance team to ensure company's work products adhere to standard operating procedures.
Reviews, edits, audits work products during different phases of biopharma operations in different operational setting (laboratory, animal, tissue procurement, and distribution operations) to support the needs of company's GxP quality system.
Supports GxP records management by ensuring records are properly organized and archived per internal procedures.
Support all aspects of company's quality management system commensurate to company's Quality Policy.
Continuously provide recommendations for improvement or best practices to facilitate company to achieve the appropriate level of quality in all appropriate work products.
Review, edit, or provide comments to various technical documents generated by Regulatory and Quality team such as regulatory dossiers, standard operating procedures, records, and other associated technical documents Work closely with company staff to ensure all appropriate work products conform to quality management systems Support maintenance and archiving of associated operational records per internal procedures in preparation of an audit by a regulatory authority Support Quality and Regulatory team by assisting with internal audits of work products to identify areas of weakness, and, when appropriate, advocate for improvement.
Assist Quality and Regulatory team by preparing, reviewing, editing, or providing valuable comments during the preparation and maintenance of various internal GxP technical documents such as standard operating procedures, regulatory dossiers (INADs and NADAs) and other technical documents intended for internal or external communication Comfortable and willing to assist as needed per supervision of senior staff in different work environments associated with all phases of biopharm operation such as office, laboratory, animal, tissue procurement, and distribution Interact as needed with various internal stakeholders, regulatory agencies, contract groups, and partner organizations to understand context of technical issues to optimize support the Quality and Regulatory Affairs team Facilitate the composition of technical documents intended for external use such as scientific abstracts, manuscripts, or presentations Perform other duties as assigned For this role you will needMinimum Requirements Bachelor's Degree in Arts/Sciences (BA/BS) in a relevant discipline 2
years of quality assurance or related experience 1
years experience working in a laboratory, animal/farm, or other manufacturing/factory environment Impeccable technical writing skills with extreme attention to detail specifically the lexicology and grammatology of written English text as applied to technical writing.
Facilitate the application of company's quality management system to company-specific processes and products to appropriate GE pig operational areas Ability to convey complex issues objectively, accurately, and thoroughly Excellent organizational, multitasking, and communication skills Strong technical knowledge and proficient in use of Microsoft office suite of applications (Outlook, Word, Excel, Powerpoint, Access, Teams, etc) Strong attention to detail and accountable to project completion Comfortable working independently and as part of a team on multiple projects with ability to rapidly change focus during times of shifting or changing priorities.
Optimist with high energy that thrives to support goals of teammates and team.
Preferred Qualifications 1
years experience technical writing for scientific publications or abstract submission, specifically for a therapeutics intended for human use 1
years experience with electronic publishing tools (eCTDs), electronic document management systems, or other specialized software used with conventional GxP systems Contributions to scientific literature via journal articles, conference abstracts or presentations Familiarity with existing regulations as it pertains to the FDA's Center for Veterinary Medicine (CVM) Investigational New Animal Drugs (INAD) and New Animal Drug Application (NADA) processes Familiarity with conventional quality management systems such as ISO 9001, 21 CFR 211, 21 CFR 820, or similar Diverse experience including biologics, drugs and medical devices 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.
#LI-Onsite 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 Recommended Skills Agriculture Attention To Detail Auditing Biotechnology Clinical Trials Communication Estimated Salary: $20 to $28 per hour based on qualifications.
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.
How you'll contributeThe Quality Assurance Specialist is responsible for maintaining cGxP quality systems in all operational phases associated with genetically engineered (GE) pigs.
Facilitates and assists the company's quality assurance team to ensure company's work products adhere to standard operating procedures.
Reviews, edits, audits work products during different phases of biopharma operations in different operational setting (laboratory, animal, tissue procurement, and distribution operations) to support the needs of company's GxP quality system.
Supports GxP records management by ensuring records are properly organized and archived per internal procedures.
Support all aspects of company's quality management system commensurate to company's Quality Policy.
Continuously provide recommendations for improvement or best practices to facilitate company to achieve the appropriate level of quality in all appropriate work products.
Review, edit, or provide comments to various technical documents generated by Regulatory and Quality team such as regulatory dossiers, standard operating procedures, records, and other associated technical documents Work closely with company staff to ensure all appropriate work products conform to quality management systems Support maintenance and archiving of associated operational records per internal procedures in preparation of an audit by a regulatory authority Support Quality and Regulatory team by assisting with internal audits of work products to identify areas of weakness, and, when appropriate, advocate for improvement.
Assist Quality and Regulatory team by preparing, reviewing, editing, or providing valuable comments during the preparation and maintenance of various internal GxP technical documents such as standard operating procedures, regulatory dossiers (INADs and NADAs) and other technical documents intended for internal or external communication Comfortable and willing to assist as needed per supervision of senior staff in different work environments associated with all phases of biopharm operation such as office, laboratory, animal, tissue procurement, and distribution Interact as needed with various internal stakeholders, regulatory agencies, contract groups, and partner organizations to understand context of technical issues to optimize support the Quality and Regulatory Affairs team Facilitate the composition of technical documents intended for external use such as scientific abstracts, manuscripts, or presentations Perform other duties as assigned For this role you will needMinimum Requirements Bachelor's Degree in Arts/Sciences (BA/BS) in a relevant discipline 2
years of quality assurance or related experience 1
years experience working in a laboratory, animal/farm, or other manufacturing/factory environment Impeccable technical writing skills with extreme attention to detail specifically the lexicology and grammatology of written English text as applied to technical writing.
Facilitate the application of company's quality management system to company-specific processes and products to appropriate GE pig operational areas Ability to convey complex issues objectively, accurately, and thoroughly Excellent organizational, multitasking, and communication skills Strong technical knowledge and proficient in use of Microsoft office suite of applications (Outlook, Word, Excel, Powerpoint, Access, Teams, etc) Strong attention to detail and accountable to project completion Comfortable working independently and as part of a team on multiple projects with ability to rapidly change focus during times of shifting or changing priorities.
Optimist with high energy that thrives to support goals of teammates and team.
Preferred Qualifications 1
years experience technical writing for scientific publications or abstract submission, specifically for a therapeutics intended for human use 1
years experience with electronic publishing tools (eCTDs), electronic document management systems, or other specialized software used with conventional GxP systems Contributions to scientific literature via journal articles, conference abstracts or presentations Familiarity with existing regulations as it pertains to the FDA's Center for Veterinary Medicine (CVM) Investigational New Animal Drugs (INAD) and New Animal Drug Application (NADA) processes Familiarity with conventional quality management systems such as ISO 9001, 21 CFR 211, 21 CFR 820, or similar Diverse experience including biologics, drugs and medical devices 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.
#LI-Onsite 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 Recommended Skills Agriculture Attention To Detail Auditing Biotechnology Clinical Trials Communication Estimated Salary: $20 to $28 per hour based on qualifications.
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