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Capa Specialist Jobs (NOW HIRING)

I am working on CAPA Specialist position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed is as follows Position: CAPA ...

Staff CAPA Specialist

Arlington, TN · On-site

$83K - $138K/yr

Hybrid We are seeking a Staff CAPA Specialist with strong CAPA and quality systems expertise who excels in a regulated environment. The ideal candidate is a collaborative problem solver who can ...

Staff CAPA Specialist

Arlington, TN · On-site

$83K - $138K/yr

Hybrid We are seeking a Staff CAPA Specialist with strong CAPA and quality systems expertise who excels in a regulated environment. The ideal candidate is a collaborative problem solver who can ...

We are currently searching for a Sr. Quality Systems Specialist- CAPA & Recall to join our team. This hybrid role is required to be on-site at our Chaska, MN headquarters three days a week. Please ...

QA Sr. Specialist - CAPA

Shirley, NY · On-site

$80K - $95K/yr

Nature and Scope The QA Senior Specialist - CAPA is responsible for ensuring that Corrective and Preventive Actions (CAPAs) and associated effectiveness checks are executed in compliance with company ...

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Capa Specialist information

What is a CAPA Specialist?

A CAPA (Corrective and Preventive Action) Specialist is responsible for managing and overseeing quality improvement processes within an organization, especially in regulated industries like pharmaceuticals, medical devices, and manufacturing. They investigate root causes of defects or non-conformities, implement corrective actions to address issues, and develop preventive measures to ensure compliance with industry standards and regulations. CAPA Specialists work closely with cross-functional teams to track and document quality improvements, ensuring continuous process enhancements. Their role is critical for maintaining product quality, regulatory compliance, and customer satisfaction.

What skills and qualifications are needed to thrive as a CAPA Specialist?

To thrive as a CAPA Specialist, you'll need a solid understanding of quality management principles, root cause analysis, and regulatory compliance, often supported by a degree in life sciences or a related technical field. Familiarity with CAPA (Corrective and Preventive Action) management systems, quality management software (such as TrackWise or MasterControl), and relevant certifications like Six Sigma or ISO 9001 are highly beneficial. Strong organizational, analytical, and communication skills, combined with attention to detail and the ability to collaborate across multiple departments, will help you excel in this role. These competencies are crucial for ensuring consistent process improvements and maintaining compliance within regulated industries such as pharmaceuticals, medical devices, or manufacturing.

What does a typical workday look like for a CAPA Specialist?

A typical workday for a CAPA Specialist involves investigating quality issues, conducting root cause analyses, and documenting findings within the CAPA management system. You'll coordinate closely with production, quality assurance, and regulatory teams to implement corrective and preventive actions and track their effectiveness over time. Expect to attend cross-functional meetings, review compliance documentation, and communicate status updates to management regularly. Your role is integral to ensuring that quality issues are properly addressed and that the organization meets both internal and external regulatory standards.

What does a Capa Specialist do?

A CAPA (Corrective and Preventive Action) Specialist is responsible for investigating quality issues, implementing corrective actions, and ensuring compliance with regulatory standards such as FDA or ISO. They analyze root causes of deviations, document findings, and collaborate with cross-functional teams to improve processes and prevent recurrence.
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Infographic showing various Capa Specialist job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 84% Full Time, 13% Part Time, and 2% Contract. Highlights an 82% Physical, 2% Hybrid, and 16% Remote job distribution.

CAPA Specialist

Durham, NC • On-site

Contractor

Re-posted 27 days ago


Job description

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on CAPA Specialist position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Position: CAPA Specialist

Location: Durham, NC
Duration: Long-Term Contract

Job Overview

We are seeking an experienced CAPA Specialist to support quality system remediation activities within a medical device manufacturing environment. The ideal candidate will have strong expertise in CAPA, Non-Conformances, Audits, Complaints, and Risk Management, with the ability to independently drive quality initiatives and ensure regulatory compliance.

Key Responsibilities

  • Lead and manage CAPAs, Non-Conformances, Complaints, and Audit activities through closure.
  • Drive quality system remediation projects and implement sustainable process improvements.
  • Develop, revise, and improve Risk Management procedures in compliance with FDA and ISO 13485 requirements.
  • Review and remediate existing quality records using risk-based decision-making.
  • Plan, conduct, and document internal and external audits.
  • Perform root cause investigations and verify CAPA effectiveness.
  • Collaborate with cross-functional teams to identify quality system gaps and implement corrective actions.
  • Ensure timely completion of quality activities while maintaining compliance with regulatory standards.

Required Qualifications

  • Bachelor's degree in Engineering, Life Sciences, or a related field.
  • Experience in the Medical Device industry is required.
  • Strong knowledge of CAPA, Non-Conformances, Complaints, Audits, and Risk Management.
  • Experience supporting or leading Quality System remediation projects.
  • Hands-on experience rewriting procedures and remediating quality records.
  • Working knowledge of FDA 21 CFR Part 820/Part 820 QMSR and ISO 13485.
  • Excellent problem-solving, documentation, and communication skills.
  • Ability to work independently in a fast-paced, regulated environment.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.  

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: karthik@starkpharma.com

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com