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ProKidney Corp. · 1 month ago

QC Analyst 3 (Contractor)

Winston-Salem, NC

Full-time, Contract

Onsite

Mid Level

3+ years exp

ProKidney Corp. is a company focused on quality control in the pharmaceutical and biotechnology sectors. The Quality Control Analyst position involves performing various testing activities to support the Quality Control department, ensuring compliance with industry standards and maintaining quality systems.

Health CareTherapeutics

No H1B

Responsibilities

Performs routine Bioanalytical testing and release of in-process, stability and REACT Final Product samples as scheduled

Executes routine and non-routine analysis, including but not limited to raw materials, in-process items and finished product according to established operating procedures; may include:

Flow Cytometry

ELISA

Kinetic Assays

Cell Counting/Viability

Visual Appearance

Initiates and Supports Deviation/OOS investigations in MasterControl

Initiates and Supports Action Item completion as assigned in MasterControl

Initiates and Supports AQEM activities as assigned in Master Control

Follows Test Methods (TSMs) Standard Operating Procedures (SOPs), Work Instructions (WRKs), and Protocols

Authors originals, revisions, and training on TSMs, SOPs, WRKs, Test Forms, and Protocols

Support QC Analytics with sample receipt from Manufacturing

Trains and mentors incoming QC Analysts (all levels)

Track and trend all QC Analytical testing performance of patient lot data along with critical reagent trending

Maintain inventory levels in QC labs and coordinate material requests with Warehouse/Supply Chain

Initiates, and participates in Change Control (MOC) management

Authors/Initiates Aborted/Invalidated Assays in the QC Analytical Lab

Complete documentation accurately and in a timely manner

Partakes in special projects on analytical methods and instrumentation problems related to execution of assays

Other duties as assigned

Qualification

Bioanalytical testingCGMP knowledgeDeviation HandlingLIMS systemsChange Control ManagementOOS Investigation experienceCommunication skillsDetail-orientedProblem-solving abilitiesDecision-making abilities

Required

Minimum of Bachelor's Degree (or better) in chemistry, biochemistry, microbiology or related science

3-5 years' experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry

Knowledge of cGMP and understanding of GxP, good clinical practices, and FDA guidelines

Familiarity with bioassays, and raw material test methods

Knowledge of LIMS systems

Deviation Handling

Change Control Management

OOS Investigation experience

Subject Matter Expertise in assays relevant to the QC Labs

Strong communication skills with the ability to interact with various individuals

Detail-oriented with problem-solving and decision-making abilities

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship

Company

ProKidney Corp.

ProKidney, a pioneer in the treatment of chronic kidney disease through innovations in cellular therapy, was founded in 2015 after a decade of research.

Founded in 2015

Salem, Oregon, USA

51-200 employees