ProKidney Corp.
Investigator, Mfg Compliance (Contract)
ProKidney Corp., Winston Salem, North Carolina, United States, 27104
Investigator, Mfg Compliance (Contract)
– ProKidney Corp. (Winston‑Salem, NC)
Position Summary Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates. The technical investigator is responsible for the initiation, investigation and completion of process deviations, change controls, and CAPAs for the assigned department, including root cause analysis, product quality impact assessment, and implementation of corrective actions.
Responsibilities
Technical writing for the educated reader, translating moderate to complex scientific events into concise, cohesive reports.
Gather data from various site sources, perform root cause analysis, assess impact on safety, quality, and product attributes, conduct trending analysis, and identify corrective and preventive actions.
Manage multiple projects and timelines concurrently, adhering to standard timelines and escalating actions appropriately.
Collaborate with appropriate departments for data gathering, process observation, and associate interviews.
Facilitate meetings, aligning internal teams and subject matter experts, resolving conflicts, and keeping meetings focused on objectives.
Understand regulatory requirements around cell therapy processing.
Lead and track change controls through the process, ensuring timely completion.
Perform other duties as assigned.
Qualifications
Undergraduate degree in a science discipline.
5+ years’ experience in a cell therapy environment.
Strong organizational skills and record‑keeping, with ability to work overtime when needed.
Ability to engage and interview co‑workers to obtain relevant information.
Strong attention to detail, communication skills (written and oral), and self‑motivation.
Familiarity with cGMP quality systems and ability to read GMP documents such as SOPs, logs, and batch records.
Strong typing and computer skills, including proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Additional Information
This is a contract position and will not include ProKidney benefits.
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, 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.
Job Details
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Other, Information Technology, and Management
Industries: Construction, Software Development, and IT Services and IT Consulting
Referrals increase your chances of interviewing at ProKidney Corp. by 2x.
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Winston‑Salem, NC .
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– ProKidney Corp. (Winston‑Salem, NC)
Position Summary Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates. The technical investigator is responsible for the initiation, investigation and completion of process deviations, change controls, and CAPAs for the assigned department, including root cause analysis, product quality impact assessment, and implementation of corrective actions.
Responsibilities
Technical writing for the educated reader, translating moderate to complex scientific events into concise, cohesive reports.
Gather data from various site sources, perform root cause analysis, assess impact on safety, quality, and product attributes, conduct trending analysis, and identify corrective and preventive actions.
Manage multiple projects and timelines concurrently, adhering to standard timelines and escalating actions appropriately.
Collaborate with appropriate departments for data gathering, process observation, and associate interviews.
Facilitate meetings, aligning internal teams and subject matter experts, resolving conflicts, and keeping meetings focused on objectives.
Understand regulatory requirements around cell therapy processing.
Lead and track change controls through the process, ensuring timely completion.
Perform other duties as assigned.
Qualifications
Undergraduate degree in a science discipline.
5+ years’ experience in a cell therapy environment.
Strong organizational skills and record‑keeping, with ability to work overtime when needed.
Ability to engage and interview co‑workers to obtain relevant information.
Strong attention to detail, communication skills (written and oral), and self‑motivation.
Familiarity with cGMP quality systems and ability to read GMP documents such as SOPs, logs, and batch records.
Strong typing and computer skills, including proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Additional Information
This is a contract position and will not include ProKidney benefits.
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, 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.
Job Details
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Other, Information Technology, and Management
Industries: Construction, Software Development, and IT Services and IT Consulting
Referrals increase your chances of interviewing at ProKidney Corp. by 2x.
Get notified about new Investigator jobs in
Winston‑Salem, NC .
#J-18808-Ljbffr