Back to jobs

QA Batch Record Release Specialist 2

Winston-Salem, North Carolina, United States

Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients’ lives. Our technology is designed to treat diseased kidneys using a patient’s own cells and may prevent or delay dialysis or transplant.

The QA Specialist II will provide essential Quality Assurance (QA) support to Quality Operations, with a primary focus on material and batch release activities. In a fast-paced pharmaceutical environment, the successful candidate will leverage strong documentation, organizational, and communication skills to ensure compliance with Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGxP) regulations. This role requires a detail-oriented individual with the ability to assess and maintain the quality of materials, products, and processes.

Essential Duties & Responsibilities:

  • Maintain GMP Databases: Ensure accurate and consistent tracking, data entry, and follow-up within departmental GMP databases.
  • Review Manufacturing and Analytical Records: Evaluate completed manufacturing, filling, labeling records, and analytical data to ensure conformance with applicable regulations, Standard Operating Procedures (SOPs), specifications, and acceptance criteria.
  • GMP System Procedure Review: Regularly review and update GMP system procedures to ensure alignment with current regulatory standards and company policies.
  • Monitor Production Activities: Perform hands-on monitoring of production and non-production activities, identifying and reporting any observed non-compliance to Quality Management.
  • Product Compliance: Ensure that finished products conform to both government and company standards while meeting cGxP regulations.
  • Batch and Material Release Documentation: Prepare and conduct initial reviews of documentation for the release of acceptable product lots and vendor materials.
  • Deviation Investigation Support: Assist in investigating deviations, identifying root causes, and proposing corrective actions.
  • SOP, Change Control, and Protocol Review: Review and provide input on SOPs, change control documents, and protocols related to cGxP programs as assigned by management.
  • Quality Metrics Reporting: Report key quality metrics and performance indicators as required.
  • Audit Participation: Participate in internal and external audits, including customer and regulatory audits, as directed by Quality Management.
  • Compliance Risk Management: Identify compliance risks, effectively communicate them to senior management, and oversee the implementation of action plans to mitigate risks.
  • Cross-Department Collaboration: Collaborate with internal departments to develop strategies and implement quality principles and regulatory requirements.
  • Escalate Critical Issues: Promptly escalate critical quality issues to senior management for resolution.
  • Stay Current with Industry Trends: Maintain up-to-date knowledge of industry trends, standards, and methodologies related to cGxP and GMP.
  • Support Quality System Implementation: Assist in the implementation and maintenance of regulated Quality Systems.

Minimum Qualifications:

  • Qualification:
    • Associate's Degree + 4 years of relevant experience
    • Bachelor's + 2 years of relevant experience
  • Knowledge:
    • Working knowledge of deviation management and CAPA resolution
    • Familiarity with FDA, EU, and ISO regulatory frameworks (preferred).
  • Skills:
    • Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers
    • Must be able to organize and prioritize work effectively to meet timelines with quality deliverables
    • Demonstrates proficiency in managing projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines
    • Proficient with Microsoft Word, Excel, Adobe

ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment. 

Apply for this job

*

indicates a required field

Resume/CV*

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

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.