Back to jobs
New

QC Analyst 3 (Contractor)

Winston-Salem, North Carolina, United States

Position Summary:
The Quality Control Analyst position involves performing various testing activities to support the Quality Control department, including bio-analytical testing, raw material testing, and protocol testing. The role requires maintaining quality systems and data generated by team members, contributing to investigations, and ensuring compliance with industry standards

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

Minimum Qualifications:

  • 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

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.

Create a Job Alert

Interested in building your career at ProKidney? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Education

Select...
Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in ProKidney’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.