Experience in writing computer system test scripts, validation protocols and summary reports ProKidney is an equal employment opportunity employer and does not discriminate against any applicant ...
Experience in writing computer system test scripts, validation protocols and summary reports ProKidney is an equal employment opportunity employer and does not discriminate against any applicant ...
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual ...
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual ...
The QA Specialist 2 provides essential Quality Assurance support to Quality Operations, with a primary focus on material and batch release activities. Working within established GMP processes and ...
The QA Specialist 2 provides essential Quality Assurance support to Quality Operations, with a primary focus on material and batch release activities. Working within established GMP processes and ...
Manufacturing Support Supervisor
$55K - $76K/yr
... ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual ...
Manufacturing Support Supervisor
$55K - $76K/yr
... ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual ...
Position Summary: As an Sr. Manager, Process Excellence, you will play a strategic role in driving efficiency, compliance, and transformation within Operational Excellence. You will guide cross ...
Position Summary: As an Sr. Manager, Process Excellence, you will play a strategic role in driving efficiency, compliance, and transformation within Operational Excellence. You will guide cross ...
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual ...
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual ...
Position Summary The Associate Director of Validation will lead the Qualification and Validation teams at the site. Serve as a member on project steering, value stream and quality systems performance ...
Position Summary The Associate Director of Validation will lead the Qualification and Validation teams at the site. Serve as a member on project steering, value stream and quality systems performance ...
Position SummaryThe Associate Director of Validation will lead the Qualification and Validation teams at the site. Serve as a member on project steering, value stream and quality systems performance ...
Position SummaryThe Associate Director of Validation will lead the Qualification and Validation teams at the site. Serve as a member on project steering, value stream and quality systems performance ...
Manufacturing Support Supervisor
$55K - $76K/yr
The Manufacturing Support Supervisor provides front-line supervision for the manufacturing support function, ensuring safe, compliant, and reliable execution of daily operations in accordance with ...
Manufacturing Support Supervisor
$55K - $76K/yr
The Manufacturing Support Supervisor provides front-line supervision for the manufacturing support function, ensuring safe, compliant, and reliable execution of daily operations in accordance with ...
Position Summary: The Team Lead, Cell Processing serves as a technical resource within the manufacturing team, supporting daily cell processing operations in a cGMP-regulated environment. This role ...
Position Summary: The Team Lead, Cell Processing serves as a technical resource within the manufacturing team, supporting daily cell processing operations in a cGMP-regulated environment. This role ...
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual ...
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual ...
Senior QA Specialist - QC Lab Operations
Winston Salem, NC · On-site
$76K - $104K/yr
Position Summary: The Senior QA Validation Specialist, QC Laboratory Operations provides independent Quality Assurance oversight and compliance support for Analytical and Microbiology laboratory ...
Senior QA Specialist - QC Lab Operations
Winston Salem, NC · On-site
$76K - $104K/yr
Position Summary: The Senior QA Validation Specialist, QC Laboratory Operations provides independent Quality Assurance oversight and compliance support for Analytical and Microbiology laboratory ...
The Manufacturing Support Specialist III plays a key leadership role in supporting manufacturing operations, with a primary focus on aseptic processing, GMP cleaning, and adherence to cGMP guidelines.
The Manufacturing Support Specialist III plays a key leadership role in supporting manufacturing operations, with a primary focus on aseptic processing, GMP cleaning, and adherence to cGMP guidelines.
The Technical Investigator is responsible for the initiation, investigation and completion of process deviations, Change Controls, and CAPA's for the assigned department. The incumbent is responsible ...
The Technical Investigator is responsible for the initiation, investigation and completion of process deviations, Change Controls, and CAPA's for the assigned department. The incumbent is responsible ...
Position Summary The Quality Assurance (QA) Specialist III provides independent, real-time QA support within classified manufacturing areas, including cleanrooms. The Specialist III applies solid ...
Position Summary The Quality Assurance (QA) Specialist III provides independent, real-time QA support within classified manufacturing areas, including cleanrooms. The Specialist III applies solid ...
Manufacturing Support Supervisor
Winston Salem, NC · On-site
$55K - $76K/yr
... ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual ...
Manufacturing Support Supervisor
Winston Salem, NC · On-site
$55K - $76K/yr
... ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual ...
Prokidney information
What are the key skills and qualifications needed to thrive as a Clinical Research Associate at Prokidney, and why are they important?
To thrive as a Clinical Research Associate at Prokidney, you need a solid background in life sciences, clinical trial regulations, and a relevant degree such as in biology, nursing, or pharmacy. Familiarity with electronic data capture (EDC) systems, Good Clinical Practice (GCP) certification, and clinical trial management software is typically required. Excellent organizational skills, attention to detail, and strong communication abilities help manage study protocols and collaborate with research teams. These skills ensure the integrity of clinical trials, regulatory compliance, and successful data collection essential for advancing Prokidney's medical innovations.
What are ProKidney jobs?
ProKidney jobs refer to positions at ProKidney, a biotechnology company specializing in the development of cell-based therapies for chronic kidney disease. Employees may work in various roles such as research and development, clinical operations, regulatory affairs, manufacturing, and corporate support. Working at ProKidney typically involves contributing to cutting-edge medical innovations aimed at improving kidney health. The company values scientific excellence, teamwork, and a commitment to advancing patient care. Joining ProKidney offers opportunities to be part of a mission-driven organization in the biotech industry.
What is the difference between Prokidney vs Dialysis Technician?
| Aspect | Prokidney | Dialysis Technician |
|---|---|---|
| Certifications | Nephrology-related certifications, patient care training | Certified Hemodialysis Technician (CHT), CPR |
| Work Environment | Nephrology clinics, hospitals, outpatient centers | Dialysis centers, hospitals |
| Industry Usage | Nephrology and kidney care | Renal dialysis services |
| Job Focus | Patient education, kidney disease management | Performing dialysis procedures, equipment setup |
Prokidney professionals focus on managing kidney disease and patient education within nephrology settings, while Dialysis Technicians primarily operate dialysis machines and perform treatments. Both roles require certifications related to dialysis and patient care, but Prokidney roles often involve broader nephrology responsibilities.
What opportunities for professional development and advancement are available for employees at ProKidney?
At ProKidney, employees are encouraged to pursue continuous professional development through in-house training programs, workshops, and cross-functional project involvement. The company fosters a collaborative environment where team members frequently interact with experts in regenerative medicine, clinical operations, and regulatory affairs, enabling them to broaden their skill sets. Career advancement is supported by regular performance reviews and opportunities to take on increased responsibilities or leadership roles as the organization grows. Employees are also encouraged to participate in industry conferences and further education related to biotechnology and healthcare innovation.
More about Prokidney jobs
What cities are hiring for Prokidney jobs? Cities with the most Prokidney job openings:
What states have the most Prokidney jobs? States with the most job openings for Prokidney jobs include:
What job categories do people searching Prokidney jobs look for? The top searched job categories for Prokidney jobs are:
Job description
Position Summary
The Associate Director of Validation will lead the Qualification and Validation teams at the site. Serve as a member on project steering, value stream and quality systems performance teams. Establish operational objectives and systems to drive employee engagement and alignment with other departments. Deliver on site objectives while implementing harmonized engineering systems and processes. Provide leadership support to the other sites and validation initiatives as needed. Will lead system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle as well as 21CFR Part11 and FDA's guide to Computer Software Assurance. Documentation includes System Validation Plan, User Requirements, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems, and Data Integrity Assessment.
Responsibilities
Qualifications
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
The Associate Director of Validation will lead the Qualification and Validation teams at the site. Serve as a member on project steering, value stream and quality systems performance teams. Establish operational objectives and systems to drive employee engagement and alignment with other departments. Deliver on site objectives while implementing harmonized engineering systems and processes. Provide leadership support to the other sites and validation initiatives as needed. Will lead system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle as well as 21CFR Part11 and FDA's guide to Computer Software Assurance. Documentation includes System Validation Plan, User Requirements, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems, and Data Integrity Assessment.
Responsibilities
- Provide leadership and direction to Validation team members, driving performance and value creation to the site function operational and strategic plans and tasks
- Ensure adequate resourcing (capacity and capability) to accomplish site and OST objectives. Recommend solutions to alleviate constraints
- Regularly interacts with senior management or executives on multi-department projects and challenges. Able to build coalitions for change.
- Continuously improving the culture of the Validation team and the site
- Represents Validation and Emergent during GMP and other regulatory agency inspections (CDC, OSHA, etc.)
- Identify areas to drive down operations costs and improve project delivery efficiency. Develop specific investment strategies to realize these savings
- Hands on troubleshooting and problem solving at the Gemba in support of engineering team members and operations
- Develop and lead small and medium sized continuous improvement projects, remain involved in projects led by staff members
- Direct support to OST head or lead annual OPEX budget for Validation department
- Staff and System Development
- Effective delegation and building confidence and competence within direct reports
- Drive engagement in the technical and personal development of the Validation team and members
- Develops strong relationships with partners (QA, Mfg., etc.) and cultivates these with all team members
- Provide effective and collaborative cross functional leadership to facilitate development of the site strategy and delivery of site objectives
- Champion and enhance the culture of the Validation team
Qualifications
- Bachelor's degree. Preferred Fields of Study: Life Sciences or Engineering
- A minimum of 10 years of experience in a biopharmaceutical or related environment in an engineering or quality related role, with at least 5 years in a leadership role
- Expert knowledge of GxPs, GAMP, CFRs/Annex 11, and Data Integrity requirements for laboratory systems and equipment (Understanding of data integrity principles and security controls including, but not limited to audit trail reviews, user access roles, disaster recovery, business continuity, system implementation, change control, archival, retirement, etc)
- Strong understanding of Validation Lifecycle (GAMP 5) principles
- Experience with calibration and maintenance management software
- Knowledge of electronic document management systems
- Experience with data integrity practices and compliance
- Strong technical writing skills for qualification documents, SOPs, and work instructions
- Ability to manage multiple projects simultaneously with minimal supervision
- Detail-oriented with excellent verbal and written communication abilities
- Ability to adapt to changing priorities in a deadline-oriented environment
- Significant hands-on experience and regulatory expectations knowledge with controls, automation and computer system validation.
- Knowledge of pharmaceutical equipment, such as bioreactors, centrifuges, HVAC systems, building chillers, clean steam generators, and Temperature Controlled Units (e.g. refrigerators, freezers, and incubators) is an advantage.
- Strong knowledge and experience in cGMP, root cause analysis, risk assessment and investigation tools/techniques.
- Experience in writing computer system test scripts, validation protocols and summary reports
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
About ProKidney
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
51 - 200 Employees
Headquarters location
Winston-Salem, NC, US
Year founded
2019