QC Microbiology Analyst 3

United States·Winston-Salemmid

Laboratory & Life SciencesMicrobiology Analyst

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Quick Summary

Overview

Position Summary: Join us in developing pioneering therapies that aim to transform the treatment of Chronic Kidney Disease (CKD) and change patients' lives.

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Responsibilities

~1 min read

→Perform Change Control and CAPA investigations, ensuring timely closure, impact assessments, and regulatory compliance.
→Support and internal and external audits.
→Generate and present metrics and trends for Management Review.
→Support training on Good Documentation Practices, Data Integrity, and Change Management.
→Review and maintain SOPs, Work Instructions, Validation studies, Risk Assessments and protocols.
→Participate in continuous improvement initiatives, harmonization efforts, and risk assessments related to quality control.
→Perform Routine Environmental Monitoring (EM) of classified GMP areas
→Conduct Personnel Monitoring during Aseptic Manufacturing Operations and EMPQ activities
→Operate, maintain and troubleshoot EM and laboratory equipment
→Adhere to Standard Operating Procedures (SOPs), Work Instructions (WIs), Protocols and safety requirements and document laboratory work consistent with cGMP requirements
→Participate in revising, and training on SOPs, WIs, Forms, and Protocols
→Supports lean initiatives in the area of lab operations, standard work, test method execution, documentation updates and equipment qualification

Requirements

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Bachelor’s degree in a science or technical discipline preferred, or equivalent experience.

3-5 years of progressive experience in quality systems within regulated pharma, biotech, or medical device industries.
Experience with commercial manufacturing and cleanroom monitoring strongly preferred.

Strong working knowledge of quality systems operations (Deviations, CAPA, Change Control, Training, Complaints, Document Control).
Excellent technical writing, training, and communication skills.
Analytical mindset with ability to trend data and identify improvement opportunities.

Strong attention to detail and organizational skills
Ability to work independently
Competence with Microsoft Office (Excel, Word, Visio); LIMS or data tracking systems a plus
Comfortable performing tasks in a cleanroom setting and wearing PPE for extended periods
Strong written and verbal communication skills
Hands-on experience with electronic QMS, particularly MasterControl (system administration and process ownership).
Hand-on experience with LIMS or sample management programs
Ability to lift up to 30 pounds and maintain good hand-eye coordination. Bending, lifting and squatting required.

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.