Back to jobs
New

QA Specialist 3, QC Lab Operations

Winston-Salem, North Carolina, United States

 

Position summary

The Quality Assurance Specialist III supports Quality of the Analytical and Microbiology Laboratories within a fast-paced, regulated cell therapy manufacturing environment. This role ensures compliance with cGMP, regulatory expectations, internal quality standards, and industry best practices. The Specialist serves as a key QA liaison to both labs, providing elevated level review, technical assessment, issue resolution, and continuous improvement support for testing activities that ensure product quality, patient safety, and data integrity.

Primary Responsibilities: 

 

  • Provide Quality Assurance oversight of daily operations within the Analytical and Microbiology laboratories to ensure full compliance with cGMP, regulatory expectations, and internal quality standards.
  • Review and approve laboratory data packages, including analytical raw data, microbiological test results, environmental monitoring results, and associated documentation for completeness, accuracy, and data integrity (including audit trail review).
  • Serve as QA reviewer for analytical and microbiology-related deviations, OOS/OOT investigations, EM excursions, and other laboratory events.
  • Assess and approve change controls relating to laboratory methods, instrumentation, workflows, and controlled documents.
  • Perform routine GxP walkthroughs of laboratory areas, identify compliance gaps, document observations, and ensure timely resolution.
  • Review and approve method validation protocols/reports, equipment qualification documents, and relevant SOPs.
  • Provide QA representation during internal audits, regulatory inspections, and laboratory readiness activities.
  • Act as QA subject matter expert (SME) for analytical testing, microbiological methods, and quality expectations related to cell therapy products. 
  • Pulling QC samples from the LN2 and storing IPC samples within the LN2.
  • Support training and mentoring of QC staff on quality principles, documentation standards, and deviation/OOLS/OOT/CAPA management.
  • Collaborate cross-functionally with QC labs, Manufacturing, Quality Systems, ASAT and Regulatory Affairs to support efficient sample testing and product release.
  • Participate in continuous improvement initiatives to enhance data integrity, streamline workflow, and strengthen laboratory compliance.
  • Contribute to risk assessments related to laboratory operations, equipment, and method lifecycle activities.
  • Review of lab system entries, electronic data workflows, and lab system upgrades.
  • Provide QA input during method transfers, new assay implementation, and introduction of new laboratory equipment or technologies.

Requirements:

  • Bachelor’s degree in Life Sciences, Microbiology, Chemistry, Biotechnology, or a related scientific field required. · Advanced degree (MS) preferred but not required
  • Minimum of 5 years of QA or QC experience in a regulated biopharmaceutical, cell therapy, biologics, or sterile manufacturing environment. ·
  • Demonstrated familiarity with analytical methods (e.g., flow cytometry, qPCR, ELISA) and microbiological techniques (e.g., sterility, endotoxin, bioburden, mycoplasma, EM). 
  •  Prior experience reviewing laboratory data under cGMP required.
  • Experience supporting or leading laboratory investigations (deviations, OOS, OOT, EM excursions)
  • Strong working knowledge of cGMP, 21 CFR Parts 210/211, Part 1271, ICH guidelines, and data integrity (ALCOA+) principles. 
  • Understanding of laboratory instrumentation, method validation, equipment qualification, and change control processes.
  • Experience with electronic systems such as LIMS, Empower, or other data acquisition platforms is preferred.
  • Excellent attention to detail and strong decision-making skills.
  • Ability to independently manage multiple priorities in a fast-paced, dynamic environment.
  • Strong communication skills to partner effectively with laboratory, manufacturing, and quality teams.
  • Ability to analyze technical data, identify compliance risks, and propose sound corrective actions.

 

 

 

 

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.