Support deviation investigations, CAPA activities, and change control processes related to quality systems documentation * Ensure compliance with FDA, cGMP, GDP, and internal quality management ...
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Support deviation investigations, CAPA activities, and change control processes related to quality systems documentation * Ensure compliance with FDA, cGMP, GDP, and internal quality management ...
Quick apply
Support deviation investigations, CAPA activities, and change control processes related to quality systems documentation * Ensure compliance with FDA, cGMP, GDP, and internal quality management ...
Summary The Quality and Training Specialist supports the organization'sQuality Management System ... Track corrective and preventive actions (CAPA) and verify effectiveness as required. Assist with ...
Summary The Quality and Training Specialist supports the organization'sQuality Management System ... Track corrective and preventive actions (CAPA) and verify effectiveness as required. Assist with ...
Summary The Quality and Training Specialist supports the organization'sQuality Management System ... Track corrective and preventive actions (CAPA) and verify effectiveness as required. Assist with ...
Summary The Quality and Training Specialist supports the organization'sQuality Management System ... Track corrective and preventive actions (CAPA) and verify effectiveness as required. Assist with ...
Indianapolis, IN · On-site
Lead daily QA activities to include record review, lead CAPA investigations and implement preventative actions. * Effectively communicates problems to production management and initiates corrective ...
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Indianapolis, IN · On-site
Lead daily QA activities to include record review, lead CAPA investigations and implement preventative actions. * Effectively communicates problems to production management and initiates corrective ...
Bloomington, IN · On-site
CAPA Development * Deviation Management * GMP Regulations * Experience using investigation tools such as: * Fishbone Analysis * 5 Whys * Failure Analysis Techniques * Familiarity with Electronic ...
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Bloomington, IN · On-site
CAPA Development * Deviation Management * GMP Regulations * Experience using investigation tools such as: * Fishbone Analysis * 5 Whys * Failure Analysis Techniques * Familiarity with Electronic ...
Lead investigation teams; partner with QA, Tech Services, and Manufacturing on CAPA * Set goals, coach performance, and conduct regular 1:1s with direct reports * Partner with HR/upper management on ...
Lead investigation teams; partner with QA, Tech Services, and Manufacturing on CAPA * Set goals, coach performance, and conduct regular 1:1s with direct reports * Partner with HR/upper management on ...
... Quality Management System (QMS) within a hands-on manufacturing environment. This role ensures ... the CAPA process, ensuring structured root cause analysis and effective corrective actions • ...
... Quality Management System (QMS) within a hands-on manufacturing environment. This role ensures ... the CAPA process, ensuring structured root cause analysis and effective corrective actions • ...
... Quality Management System (QMS) within a hands-on manufacturing environment. This role ensures ... CAPA process, ensuring structured root cause analysis and effective corrective actions Monitor CAPA ...
... Quality Management System (QMS) within a hands-on manufacturing environment. This role ensures ... CAPA process, ensuring structured root cause analysis and effective corrective actions Monitor CAPA ...
Fort Wayne, IN · On-site
Manage risk assessments and the Corrective and Preventive Action (CAPA) process. * Collaboration: work with business leaders, to identify quality system changes that would drive improvement within ...
New
Fort Wayne, IN · On-site
Manage risk assessments and the Corrective and Preventive Action (CAPA) process. * Collaboration: work with business leaders, to identify quality system changes that would drive improvement within ...
New
DUTIES & RESPONSIBILITIES · Own and maintain the company's Quality Management System (QMS) within ... the CAPA process, ensuring structured root cause analysis and effective corrective actions · ...
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DUTIES & RESPONSIBILITIES · Own and maintain the company's Quality Management System (QMS) within ... the CAPA process, ensuring structured root cause analysis and effective corrective actions · ...
Indianapolis, IN · On-site
$87K/yr
Support service management processes including incident, change, and access management Assist with CAPA activities and ensure proper documentation and follow-through Maintain validation documentation ...
Indianapolis, IN · On-site
$87K/yr
Support service management processes including incident, change, and access management Assist with CAPA activities and ensure proper documentation and follow-through Maintain validation documentation ...
Job Responsibilities: · Manages the review cycle of customer complaints and CAPA's · Lead internal audit program · Assist in the development, revision, and control of Standard Operating Procedures ...
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Job Responsibilities: · Manages the review cycle of customer complaints and CAPA's · Lead internal audit program · Assist in the development, revision, and control of Standard Operating Procedures ...
South Bend, IN · On-site
$18 - $23/hr
... management systems experience. * Previous experience of production/manufacturing and quality experience. * Knowledge of quality system processes such as batch record review, product release, CAPA ...
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South Bend, IN · On-site
$18 - $23/hr
... management systems experience. * Previous experience of production/manufacturing and quality experience. * Knowledge of quality system processes such as batch record review, product release, CAPA ...
... management systems experience. * Previous experience of production/manufacturing and quality experience. * Knowledge of quality system processes such as batch record review, product release, CAPA ...
... management systems experience. * Previous experience of production/manufacturing and quality experience. * Knowledge of quality system processes such as batch record review, product release, CAPA ...
Warsaw, IN · On-site
$70K - $90K/yr
Manages projects and new product launches. Creates conceptual designs for fixtures, gages and ... Completes activities of the change control policy and Corrective and Preventive Action (CAPA ...
Warsaw, IN · On-site
$70K - $90K/yr
Manages projects and new product launches. Creates conceptual designs for fixtures, gages and ... Completes activities of the change control policy and Corrective and Preventive Action (CAPA ...
Job Responsibilities: · Manages the review cycle of customer complaints and CAPA's · Lead internal audit program · Assist in the development, revision, and control of Standard Operating Procedures ...
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Job Responsibilities: · Manages the review cycle of customer complaints and CAPA's · Lead internal audit program · Assist in the development, revision, and control of Standard Operating Procedures ...
Job Responsibilities: · Manages the review cycle of customer complaints and CAPA's · Lead internal audit program · Assist in the development, revision, and control of Standard Operating Procedures ...
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Job Responsibilities: · Manages the review cycle of customer complaints and CAPA's · Lead internal audit program · Assist in the development, revision, and control of Standard Operating Procedures ...
Indianapolis, IN · On-site
Optimize CAPA and Deviation lifecycle processes through structured improvement efforts * Deploy ... Manage cross-functional stakeholder engagement across Quality, Regulatory, Manufacturing, and ...
Indianapolis, IN · On-site
Optimize CAPA and Deviation lifecycle processes through structured improvement efforts * Deploy ... Manage cross-functional stakeholder engagement across Quality, Regulatory, Manufacturing, and ...
South Bend, IN · On-site
$18 - $23/hr
... management systems experience. * Previous experience of production/manufacturing and quality experience. * Knowledge of quality system processes such as batch record review, product release, CAPA ...
South Bend, IN · On-site
$18 - $23/hr
... management systems experience. * Previous experience of production/manufacturing and quality experience. * Knowledge of quality system processes such as batch record review, product release, CAPA ...
Job Responsibilities: · Manages the review cycle of customer complaints and CAPA's · Lead internal audit program · Assist in the development, revision, and control of Standard Operating Procedures ...
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Job Responsibilities: · Manages the review cycle of customer complaints and CAPA's · Lead internal audit program · Assist in the development, revision, and control of Standard Operating Procedures ...
$12.84 - $16.68
2% of jobs
$16.68 - $20.51
5% of jobs
$20.51 - $24.34
8% of jobs
$24.34 - $28.17
8% of jobs
$28.59 is the 25th percentile. Wages below this are outliers.
$28.17 - $32
9% of jobs
$32 - $35.83
8% of jobs
The median wage is $38.62 / hr.
$35.83 - $39.66
11% of jobs
$39.66 - $43.49
21% of jobs
$43.77 is the 75th percentile. Wages above this are outliers.
$43.49 - $47.32
15% of jobs
$47.32 - $51.15
6% of jobs
$51.15 - $54.98
5% of jobs
$12
$37
$54
A CAPA (Corrective and Preventive Action) Manager is responsible for overseeing an organization's CAPA process to ensure compliance with quality and regulatory requirements. They investigate quality issues, identify root causes, and implement corrective and preventive measures to prevent recurrence. CAPA Managers work closely with cross-functional teams to improve processes, maintain regulatory compliance, and enhance overall product or service quality.
One common challenge CAPA Managers face is ensuring timely and thorough investigations into quality issues while coordinating input from multiple departments. Balancing the need for fast resolution with the rigor required for regulatory compliance can be demanding, especially in highly regulated industries like pharmaceuticals or medical devices. Successful CAPA Managers often address these challenges through clear process documentation, effective project management, and fostering strong collaboration among stakeholders. By leveraging root cause analysis tools and maintaining open communication, they help create a continuous improvement culture that benefits both the organization and its customers.
To thrive as a CAPA Manager (Corrective and Preventive Action Manager), you typically need a background in quality assurance, strong analytical and problem-solving abilities, and experience with regulatory compliance, often supported by a degree in a science or engineering field. Familiarity with quality management systems (QMS), risk management tools, root cause analysis methodologies (such as 5 Whys or Fishbone diagrams), and industry certifications like Six Sigma or ISO 9001 are highly valued. Outstanding candidates demonstrate excellent communication, leadership, and organizational skills to effectively drive cross-functional teams and ensure timely resolution of quality issues. These skills are crucial for identifying, addressing, and preventing compliance gaps or product issues, thereby maintaining high standards and avoiding costly regulatory penalties.
Contractor
Re-posted 16 days ago
Job Title: Quality Assurance Specialist
Location: Indianapolis, IN
Duration: Long Term
Job Summary
We are seeking a detail-oriented Quality Assurance Specialist to support quality agreement management activities within a GMP-regulated pharmaceutical/biotech environment. The ideal candidate will be responsible for drafting, reviewing, negotiating, and maintaining quality agreements to ensure compliance with GxP regulations and internal quality standards.
The Quality Assurance Specialist will collaborate with internal cross-functional teams and external partners to support supplier qualification, regulatory compliance, and manufacturing readiness activities.
Key Responsibilities
Experience