Top 4 Qc microbiology analyst 3 Jobs in Winston, Nc

QC Analyst 3
ProKidney —Winston-Salem, NC
- 5 years
- Bachelor's degree
- US work authorization
QC Microbiology Analyst 3
ProKidney —Winston-Salem, NC
- Microsoft Excel
- Mid-level
- 3 years
QC Finished Product Supervisor
Thermo Fisher Scientific —High Point, NC
- Full-time
- Supervising experience
- Bachelor's degree
- Mentoring

Other jobs to consider

Find your next job by exploring related positions.

QC Microbiology Analyst 3
ProKidney —Winston-Salem, NC
Bachelor’s degree in a science or technical discipline preferred, or equivalent experience. This role involves monitoring during manufacturing operations,…
QC Analyst 3
ProKidney —Winston-Salem, NC
This position plays a key role in ensuring the technical operations of QC, focusing on the technical suitability of bioanalytical test methods rather than day-…

I want to receive the latest job alert for qc microbiology analyst 3 in winston, nc

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

qc microbiology analyst 3 jobs near winston, nc

QC Technician jobs in Winston-Salem, NC

Quality Assurance jobs in Orlando, FL

Quality Control Supervisor jobs in Maryland

Supervisor Curriculum Instruction jobs in New Jersey

Quality Control Supervisor jobs in New Hampshire

Quality Control Supervisor jobs in Irvine, CA

Quality Control Supervisor jobs in Arizona

Animal Control Officer jobs in Sacramento, CA

Supervisor jobs in Phoenix, AZ

Qc Technician jobs in Rochester, NY

Qc Technician jobs in Muskogee, OK

Behavior Technician jobs in Chula Vista, CA

Sterile Processing Technician jobs in Bridgeport, CT

Qc Technician jobs in Pittsburg, CA

Qc Technician jobs in Arlington Heights, IL

Audio Technician jobs in Atlanta, GA

Qc Technician jobs in Seattle, WA

Dental Technician jobs in Riverside, CA

Behavior Technician jobs in Washington, DC

Qc Technician jobs in Kansas City, MO

QC Analyst 3

ProKidney
Winston-Salem, NC

Apply Now

Job Details

Qualifications

USP standards
Laboratory equipment performance testing and validation
Analytical chemistry
Pharmaceutical regulatory compliance
Laboratory instrument validation
Equipment malfunction troubleshooting
ICH guidelines
Equipment testing
Test validation method

Full Job Description

Position Summary
The QC Analyst 3 will support various duties within the Quality Control (QC) department. This position plays a key role in ensuring the technical operations of QC, focusing on the technical suitability of bioanalytical test methods rather than day-to-day product testing. The role includes responsibility for the analytical method lifecycle, including method transfer, validation, compendial verification, performance monitoring, and continuous improvement, as well as ensuring analytical equipment is installed and qualified. The QC Analyst will support ProKidney's pipeline, from Phase III clinical development through commercial operations.

Responsibilities

Writes and executes procedures for analytical method protocols, generating reports related to QC method transfer, validation, and verification.
May write standard operating procedures (SOPs), protocols, and/or participate in instrument qualifications and analytical system validation.
Support monitoring of analytical method performance, including assessment of analytical method system suitability requirements.
Assist with data trending and aid in compilation of trend reports utilizing statistical tools.
Work with internal departments to ensure system lifecycle document readiness and support analytical instrument qualification and system validation.
Present to cross-functional teams and effectively communicate critical analytical issues and solutions.
Familiarity with FDA and EMA guidance documents relevant to cell therapy, and compendial methods from USP and EP.
Working knowledge of quality systems requirements.
Ability to work in a fast-paced, collaborative environment, managing workload based on changing priorities.
Demonstrated leadership skills and the ability to collaborate with and effectively influence others.
Establish, revise, review, perform gap-assessment, and maintain procedures (including protocols and technical reports).
Assure laboratory procedures are compliant with current requirements and facilitate updates as needed.
Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
Maintain QC lab and related systems to ensure compliance with industry standards and inspection readiness.
Support CAPA's, deviations, investigations, and OOS's, ensuring effective resolution and continuous improvement.
Other tasks as assigned.

Qualifications

Bachelor's degree or equivalent in Chemistry/Biochemistry, or a related discipline.
Minimum of 5 years of relevant professional experience, including a combination of Quality Control, Analytical Development, or Microbiology. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed.
Troubleshoot equipment and analytical testing methods.
Prior experience with analytical method validations.
Excellent technical writing skills.
Familiar with ICH quality guidelines and their application in QC laboratory environments.
Thorough understanding of industry testing requirements/standards.
Excellent time management skills; organized and able to meet company deadlines.
Ability to work and prioritize under pressure in an international environment.
Familiar with FDA and EMA guidance documents relevant to gene therapy.
Experience with Analytical Instrument Qualification and System Validation in laboratory environments.
Familiarity with compendial methods including USP and EP.

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.

Apply Now

Refine Your Search

qc microbiology analyst 3 jobs in winston, nc

QC Analyst 3

QC Microbiology Analyst 3

QC Finished Product Supervisor

Other jobs to consider

I want to receive the latest job alert for qc microbiology analyst 3 in winston, nc

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected