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Capa Specialist Jobs (NOW HIRING)

American Regent, Inc.

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 ...

ECHO Consulting Group

OH · On-site

Own the CAPA identification, implementation, and effectiveness-verification phases for assigned investigations. * Review and approve deviation, nonconformance, and CAPA records within the Quality ...

DivIHN Integration Inc

CAPA/NCR Writer

Round Lake, IL · On-site

Please apply or call one of us to learn more For further inquiries regarding the following opportunity, please contact our Talent Specialist: Hema Malini at (630) 847 0275 Title: CAPA/NCR Writer ...

Highridge Medical

QMS Specialist

Westminster, CO · On-site

QMS Specialist Principal Duties and Responsibilities Material Documentation Support and Testing ... Coordinate CAPA meetings, establish meeting times, locations, agenda, and maintain meeting minutes.

Highridge Medical

QMS Specialist

Westminster, CO · On-site

QMS Specialist Principal Duties and Responsibilities Material Documentation Support and Testing • ... Identify appropriate metrics and trend CAPA metrics and present defined reports at specified ...

Polymer Technology Systems, Inc

NY · On-site

Compliance Specialist Full-time Regular Professional Whitestown, IN, US 3 days ago Requisition ID ... Minimum 3 years' experience with CAPA systems, including complaint handling * Minimum 3 years ...

Medasource

Complaint Handling Specialist

Madison, WI · On-site

Complaint Handling Specialist Location: Madison, WI | Onsite Employment Type: Full-Time, Direct ... This role will have a strong focus on complaint investigations, MDR/vigilance reporting, CAPA ...

Certified Employment Group

Be Seen First

Quality Systems & Training Specialist

Santa Rosa, CA · On-site

$30 - $38/hr

QUALITY SYSTEMS & TRAINING SPECIALIST Santa Rosa, CA | $30-$38/hr DOE Position Summary Responsible ... Manage CAPA and complaint processes from investigation through closure. * Track audit findings ...

Symmetrio

Senior Quality Assurance Specialist

Richland, WA · On-site

$86K - $118K/yr

The Senior Quality Assurance Specialist will manage nonconformance and CAPA activities, support internal and external audits, monitor quality performance indicators, and help strengthen the ...

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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, 74% Full Time, 23% Part Time, and 2% Contract. Highlights an 85% Physical, 2% Hybrid, and 13% Remote job distribution.

QA Sr. Specialist - CAPA

Shirley, NY • On-site

American Regent, Inc.
Pharmaceutical and Medicine Manufacturing • 501 - 1,000 employees
Learn more about American Regent, Inc.external

$80K - $95K/yr

Full-time

Medical, Life, Retirement, PTO

Re-posted 21 days ago

Key responsibilities

  • Coordinate departmental activities to ensure the effective execution of CAPAs and associated effectiveness checks in compliance with SOPs, policies, and cGMP requirements.

  • Support and facilitate the investigation, documentation, and timely completion of Corrective and Preventive Actions related to sterile pharmaceutical manufacturing.

  • Participate in quality system activities such as internal audits, review of quality data and metrics, inspection readiness, and continuous improvement initiatives.

American Regent rating

7.2

Company rating: 7.2 out of 10

Based on 12 frontline employees who took The Breakroom Quiz

Job description

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 SOPs, internal policies, and applicable cGMP requirements. This role also supports the customer SNCR process, regulatory audit activities, and the Quality Council process. This is a cross-functional position that collaborates with all departments across American Regent. The incumbent will actively participate in planning, implementing, and maintaining quality systems to meet or exceed the company's quality standards and regulatory expectations.
Essential Duties and Responsibilities
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
  • Coordinate specific departmental activities with the goal of maximizing efficiency of management control systems, programs, policies, work methods and procedures. Collaborate with QA staff, colleagues, and leadership to ensure that goals and objectives are accomplished in a timely manner.
    • Interact and maintain relationships with colleagues, investigators, CAPA owners and staff in facilitating department objectives and ensuring positive working interactions.
    • Provide detailed attention to carry out activities in support of the QA Department with interrelated activities of other programs, departments or staff and communicate within the appropriate timeframe.
    • Work independently and recognize daily needs to be met with minimal supervision while delivering timely results.
    • Effectively manage multiple tasks.

  • Ensure any Corrective / Preventative Actions and Effectiveness Checks associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated, written and documented in accordance with company SOPs, policies and cGMPs and within assigned timelines. Identify issues, evaluate metrics and provide support for internal audits under the direction of the QA Supervisor.
    • Ensure CAPA and Effectiveness timelines are maintained through inter-department communication with escalations as necessary.
    • Facilitate meetings to drive aging CAPAs and Effectiveness Checks to completion.
    • Review of Quality Systems data and metrics for trends within assigned area of support and report to QA Manager.
    • Confirm the completeness, accuracy and consistency of all work so that it meets the standards of quality. Identify errors and inconsistencies and initiate resolution to ensure high quality.
    • Complete monthly metrics for CAPA and Effectiveness Checks.
  • Additional Quality System Support
  • Support inspection readiness for regulatory inspections and internal or third-party audits.
  • Provide support for customer Non-Compliance reports received (SNCRs).
  • Support Quality Council and Management Review meetings, including preparation and follow-up activities.
  • Participate in cross-functional training with the QA Deviations team as needed.
  • Participate in continuous improvement initiatives to enhance the Quality System.
    • Identify and participate in initiatives to continuously improve the Quality System.
    • Represent the QA group in continuous improvement committees or working groups.
  • Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
  • Bachelor's degree in a science or engineering discipline required.
  • 5+ years of Quality Assurance experience in a regulated environment, required.
  • Knowledge of applicable FDA regulations, and experience in interpreting and applying to the organization, required.
  • Strong analytical, critical thinking, and problem-solving skills.
  • Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. Ability to effectively present information to top management, employees, or customers.
  • Demonstrate experience in CAPA writing, documenting issues, impact assessment, and risk management.
  • Understanding of how the pharmaceutical process pathway works, specifically how each of the various disciplines interact with each other.
  • Exceptional organizational and time management skills with the ability to effectively manage multiple tasks.
  • Detail-oriented with the ability to work independently and collaboratively in a team environment.
  • Computer skills to include Microsoft Word, Excel, PowerPoint, preferred.

Expected Salary Range:
$80,000 - $95,000
The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.
American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
Applicants have rights under Federal Employment Laws.
  • FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
  • Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
  • Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

Alert: We're aware of individuals impersonating our staff to target job seekers. Please note:
• All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.
• Our recruiting process includes multiple in person and/or video interviews and assessments.
• If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding.
• We never request payment, bank information, or personal financial details during our offer process.
Your security is important to us, and we encourage you to stay vigilant when job searching.
American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.

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