Support quality system activities related to CAPA (Corrective and Preventive Actions), NCR (Non-Conformance Reports), and planned deviations. * Provide validation support as needed, including ...
Support quality system activities related to CAPA (Corrective and Preventive Actions), NCR (Non-Conformance Reports), and planned deviations. * Provide validation support as needed, including ...
Quality Associate I (TEMPORARY)
South Bend, IN · On-site
$18 - $23/hr
Support quality system activities related to CAPA (Corrective and Preventive Actions), NCR (Non-Conformance Reports), and planned deviations. * Provide validation support as needed, including ...
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Quality Associate I (TEMPORARY)
South Bend, IN · On-site
$18 - $23/hr
Support quality system activities related to CAPA (Corrective and Preventive Actions), NCR (Non-Conformance Reports), and planned deviations. * Provide validation support as needed, including ...
Quality Associate I (TEMPORARY)
South Bend, IN · On-site
$18 - $23/hr
Support quality system activities related to CAPA (Corrective and Preventive Actions), NCR (Non-Conformance Reports), and planned deviations. * Provide validation support as needed, including ...
Quality Associate I (TEMPORARY)
South Bend, IN · On-site
$18 - $23/hr
Support quality system activities related to CAPA (Corrective and Preventive Actions), NCR (Non-Conformance Reports), and planned deviations. * Provide validation support as needed, including ...
Manufacturing Quality Assurance (QA) Engineer
Indianapolis, IN · On-site
$68 - $80K/hr
Own CAPA (Corrective and Preventive Action) processes, including CAPA administration, tracking, effectiveness verification, and timely closure. Lead root cause analysis and ensure systemic corrective ...
Manufacturing Quality Assurance (QA) Engineer
Indianapolis, IN · On-site
$68 - $80K/hr
Own CAPA (Corrective and Preventive Action) processes, including CAPA administration, tracking, effectiveness verification, and timely closure. Lead root cause analysis and ensure systemic corrective ...
Support equipment startup, commissioning, and compliance activities (deviations/CAPA) Qualifications * 3+ years of maintenance experience in a GMP environment * Experience with manufacturing or lab ...
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Support equipment startup, commissioning, and compliance activities (deviations/CAPA) Qualifications * 3+ years of maintenance experience in a GMP environment * Experience with manufacturing or lab ...
Participate in deviation investigations, CAPA implementation, and continuous improvement of CQV processes.
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Participate in deviation investigations, CAPA implementation, and continuous improvement of CQV processes.
Quality Manager
Elkhart, IN · On-site
$65K - $80K/yr
Analyze quality metrics, identify root causes of defects, and implement corrective and preventive actions (CAPA). * Partner closely with production, engineering, and operations teams to improve ...
Quality Manager
Elkhart, IN · On-site
$65K - $80K/yr
Analyze quality metrics, identify root causes of defects, and implement corrective and preventive actions (CAPA). * Partner closely with production, engineering, and operations teams to improve ...
Maintenance Technician
Indianapolis, IN · On-site
Experience working in FDA/cGMP environments, interpreting P&IDs and electrical schematics, using CMMS, and supporting commissioning, calibrations, deviations, and CAPA activities is highly preferred.
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Maintenance Technician
Indianapolis, IN · On-site
Experience working in FDA/cGMP environments, interpreting P&IDs and electrical schematics, using CMMS, and supporting commissioning, calibrations, deviations, and CAPA activities is highly preferred.
Maintain and monitor quality systems, including document control, change control, CAPA (Corrective and Preventive Actions), internal audits, and complaint handling. Job Responsibilities: · Manages ...
New
Quick apply
Maintain and monitor quality systems, including document control, change control, CAPA (Corrective and Preventive Actions), internal audits, and complaint handling. Job Responsibilities: · Manages ...
New
System Support Analyst
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 ...
System Support Analyst
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 ...
This specialist will be assigned straightforward CAPA related to SOP/WI revisions. Process Specialist - (II / Base) To work closely with MFG and QA systems to provide support for deviation ...
This specialist will be assigned straightforward CAPA related to SOP/WI revisions. Process Specialist - (II / Base) To work closely with MFG and QA systems to provide support for deviation ...
Oversee the Corrective Action and Preventive Action (CAPA) process or designate a member of Quality to ensure the CAPA procedure is followed and the CAPA system is effective * Performs statistical ...
New
Oversee the Corrective Action and Preventive Action (CAPA) process or designate a member of Quality to ensure the CAPA procedure is followed and the CAPA system is effective * Performs statistical ...
New
This specialist will be assigned straightforward CAPA related to SOP/WI revisions. Process Specialist - (II / Base) To work closely with MFG and QA systems to provide support for deviation ...
Quick apply
This specialist will be assigned straightforward CAPA related to SOP/WI revisions. Process Specialist - (II / Base) To work closely with MFG and QA systems to provide support for deviation ...
This specialist will be assigned straightforward CAPA related to SOP/WI revisions. Process Specialist - (II / Base) To work closely with MFG and QA systems to provide support for deviation ...
Quick apply
This specialist will be assigned straightforward CAPA related to SOP/WI revisions. Process Specialist - (II / Base) To work closely with MFG and QA systems to provide support for deviation ...
This specialist will be assigned straightforward CAPA related to SOP/WI revisions. Process Specialist - (II / Base) To work closely with MFG and QA systems to provide support for deviation ...
This specialist will be assigned straightforward CAPA related to SOP/WI revisions. Process Specialist - (II / Base) To work closely with MFG and QA systems to provide support for deviation ...
Process Specialist
Fishers, IN · On-site
This specialist will be assigned straightforward CAPA related to SOP/WI revisions. Process Specialist - (II / Base) To work closely with MFG and QA systems to provide support for deviation ...
Process Specialist
Fishers, IN · On-site
This specialist will be assigned straightforward CAPA related to SOP/WI revisions. Process Specialist - (II / Base) To work closely with MFG and QA systems to provide support for deviation ...
Process Specialist
Fishers, IN · On-site
This specialist will be assigned straightforward CAPA related to SOP/WI revisions. Process Specialist - (II / Base) To work closely with MFG and QA systems to provide support for deviation ...
Process Specialist
Fishers, IN · On-site
This specialist will be assigned straightforward CAPA related to SOP/WI revisions. Process Specialist - (II / Base) To work closely with MFG and QA systems to provide support for deviation ...
Process Specialist
Fishers, IN · On-site
This specialist will be assigned straightforward CAPA related to SOP/WI revisions. Process Specialist - (II / Base) To work closely with MFG and QA systems to provide support for deviation ...
Process Specialist
Fishers, IN · On-site
This specialist will be assigned straightforward CAPA related to SOP/WI revisions. Process Specialist - (II / Base) To work closely with MFG and QA systems to provide support for deviation ...
Manufacturing Quality Engineer, Joining & Regulatory
Warsaw, IN · On-site
$71K - $92K/yr
Maintain audit readiness: documentation control, traceability, training records, and CAPA follow-through. Bonding Engineering (Glass, PP-GF, Urethane) * Develop and validate bonding processes for ...
Manufacturing Quality Engineer, Joining & Regulatory
Warsaw, IN · On-site
$71K - $92K/yr
Maintain audit readiness: documentation control, traceability, training records, and CAPA follow-through. Bonding Engineering (Glass, PP-GF, Urethane) * Develop and validate bonding processes for ...
Process Specialist
Fishers, IN · On-site
This specialist will be assigned straightforward CAPA related to SOP/WI revisions. Process Specialist - (II / Base) To work closely with MFG and QA systems to provide support for deviation ...
Process Specialist
Fishers, IN · On-site
This specialist will be assigned straightforward CAPA related to SOP/WI revisions. Process Specialist - (II / Base) To work closely with MFG and QA systems to provide support for deviation ...
Capa information
See Indiana salary details
$13.97 - $18.70
0% of jobs
$18.70 - $23.44
6% of jobs
$23.44 - $28.17
11% of jobs
$30.04 is the 25th percentile. Wages below this are outliers.
$28.17 - $32.90
20% of jobs
The median wage is $36.96 / hr.
$32.90 - $37.63
15% of jobs
$37.63 - $42.36
15% of jobs
$44.73 is the 75th percentile. Wages above this are outliers.
$42.36 - $47.10
16% of jobs
$47.10 - $51.83
9% of jobs
$51.83 - $56.56
4% of jobs
$56.56 - $61.29
2% of jobs
$61.29 - $66.03
2% of jobs
$13
$39
$66
How much do capa jobs pay per hour?
What are the typical daily responsibilities of a CAPA specialist?
A CAPA specialist is responsible for investigating quality issues, identifying root causes, and implementing corrective and preventive actions to ensure ongoing compliance and product integrity. Their typical day involves reviewing nonconformance reports, collaborating with cross-functional teams, documenting findings, and tracking the progress of CAPA initiatives using specialized software. CAPA specialists also prepare reports for audits and may facilitate meetings to drive continuous improvement activities. This role often requires balancing multiple projects and deadlines in a regulated environment, making organizational and communication skills crucial for success.
What are the key skills and qualifications needed to thrive in the Capa position, and why are they important?
To thrive as a CAPA (Corrective and Preventive Action) specialist, you need expertise in quality management systems, root cause analysis, and compliance with industry standards, typically backed by a degree in engineering, life sciences, or a related field. Familiarity with CAPA software, regulatory frameworks (such as ISO 13485 or FDA 21 CFR Part 820), and document control systems is essential. Strong analytical thinking, attention to detail, and effective communication skills are vital soft skills for this role. These skills ensure effective problem-solving and sustained compliance, which are essential for maintaining product quality and meeting regulatory requirements.
What is a CAPA job?
A CAPA (Corrective and Preventive Action) job involves identifying, investigating, and resolving quality issues in industries like manufacturing, healthcare, and pharmaceuticals. CAPA professionals analyze root causes of defects or process failures and implement corrective actions to prevent recurrence. They ensure compliance with regulatory standards, document findings, and improve overall quality management systems. Their role is critical in maintaining product safety, efficiency, and regulatory adherence.

Full-time
Posted 16 days ago
Job description
Full-time, Temporary
Description
TEMPORARY, FULL-TIME Onsite Position
3 months - 6 months
SUMMARY OF POSITION:
The Quality Associate I is responsible for supporting day-to-day quality activities to ensure compliance with the Quality Management System, and procedures therein, and applicable regulatory requirements.
ESSENTIAL FUNCTIONS, included but not limited to:
- Partner with other departments, as needed to maintain product quality, drive and/or support continuous improvement, and ensure accurate and complete documentation.
- Perform batch record review and release activities to ensure all documentation is complete , accurate, and compliant with established procedures and quality standards.
- Perform release activities for materials, components, and finished products, etc.
- Conduct various testing activities, including but not limited to quality control (QC), water testing, Total Organic Carbon (TOC), stability-related activities, and other routine quality testing as assigned.
- Perform environmental monitoring (EM) activities as required.
- Conduct calibration activities for equipment and instruments, including but not limited to weights, thermometers, thermocouples, and other measurement devices.
- Assist with troubleshooting, root cause analysis, and continuous process improvement initiatives to enhance product quality and operational efficiency.
- Support quality system activities related to CAPA (Corrective and Preventive Actions), NCR (Non-Conformance Reports), and planned deviations.
- Provide validation support as needed, including execution and documentation assistance for validation protocols and reports.
- Provide document control support as needed.
- Assist with solution preparation activities as needed, following approved procedures and specification requirements.
- Perform analysis and trending of Quality data as needed to support investigations, process monitoring, and continuous improvement.
- Support internal and external audits, as required.
- Adhere to current Good Manufacturing Practices (cGMP).
- Comply with Company policies, Quality Management System (QMS) and Standard Operation Procedure (SOPs), etc.
OTHER FUNCTIONS:
- Ensure compliance with safety regulations and procedures are implemented and followed; Maintain clean and safe work area.
- Assist as needed in other areas of the company where training requirements have been completed.
- Perform other duties as assigned.
SUPERVISORY RESPONSIBILITIES:
- None
TRAVEL:
- None
Requirements
REQUIRED QUALIFICATIONS:
- Legally authorized to work in the United States.
- High School Diploma or its equivalent.
- Proven quality management systems experience.
- Previous experience of production/manufacturing and quality experience.
- Knowledge of quality system processes such as batch record review, product release, CAPA, deviations, NCRs, document control and validation support.
- Familiarity with statistical process control principles used to monitor and ensure the quality of the production process.
- Ability to perform routine testing and interpret basic quality data.
- Good understanding of laboratory equipment (e.g., pipettes, scales, pH meters).
- Experience using inspection and measurement tools such as calipers, micrometers, multimeters, or similar equipment
- General knowledge of biological and chemical concepts.
- Familiarity with various standards and regulations such as ISO 9001, ISO 13485:2016, the Quality System Regulation (21 CFR Part 820)
PREFERRED QUALIFICATIONS:
- Associate or bachelor's degree in Biology, Chemistry, Quality, Life Sciences, Engineering, or a related scientific/technical field.
- Experience supporting quality audits, root cause analysis, or corrective actions
- Experience with document control, CAPA, and internal auditing.
- Ability to analyze quality metrics and process data to identify improvement opportunities.
- Direct laboratory experience in a biology, chemistry, or medical environment.
- Experience with performing QC Testing, including assays
- Ability to operate laboratory equipment and understand complex testing protocols including analytical pipetting, enzyme assays, High-Performance Liquid Chromatography (HPLC), and electrophoresis.
- General knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) or similar.
BASIC SKILLS AND ABILITIES:
- Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude.
- Detail oriented with a high level of accuracy, efficiency, and accountability.
- Possess a strong commitment to product quality and compliance.
- Excellent organizational skills to meet goals and set priorities.
- Ability to work independently and as a member of various teams and committees.
- Proven ability to handle multiple projects and meet deadlines; work in a fast-paced environment.
- Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
- Willingness to pivot between lab testing, documentation review, and floor support.
- Ability to operate related office equipment, such as computers, calculator, and copier.
- Able to work with small tools and electronic equipment to test and inspect.
- Demonstrated ability to analyze and interpret information.
- Ability to perform repetitive tasks and use laboratory/manufacturing instruments.
- Working knowledge of Microsoft Excel, Word, and Outlook.
REASONING ABILITIES:
- Able to understand the basic reasoning and process of the scientific method.
- Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
LANGUAGE SKILLS:
- Ability to read and interpret work related documents, procedures, and manuals.
- Ability to communicate effectively; good written and oral communication skills; ability to read, write, speak, and understand the English language.
MATHEMATICAL SKILLS:
- Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
- General knowledge of the metric system units (length, area, volume, capacity, mass, and weight) and U.S. equivalents.
VISUAL ACUITY:
- Close visual acuity to perform an activity such as preparing and analyzing data, transcribing, viewing a computer terminal, and reading.
PHYSICAL DEMANDS:
- Ability to work in a laboratory, manufacturing, or controlled environment.
- Must be able to wear and work in personnel protective equipment (PPE) as required.
- Light physical activity performing non-strenuous daily activities in a laboratory setting.
- Ability to hear, understand, and distinguish speech.
- Dexterity and coordination are necessary to handle small components.
- Manual dexterity required for handling samples and performing precise calibrations.
- Frequent repetitive motions that may include the wrists, hands and/or fingers to operate keyboard and mouse.
- Frequently stand for prolonged periods of time.
- Occasionally move about inside the facility to access office machinery, correspond with other departments, attend meetings/training, etc.
- Frequently lift, carry, push, pull or otherwise move objects up to 10 pounds; occasionally carry, push, pull or otherwise move objects up to 25 pounds.
- Occasionally required to climb or balance; squat, stoop, kneel, crouch, or crawl; and smell.
- Occasionally reaching for items above and below desk level.
- The ability to hear, understand, and distinguish speech.
- Frequently communicate information and ideas with others to exchange information and understanding. Able to exchange accurate information in these situations.
ENVIRONMENT CONDITIONS:
- Well lit, heated/air-conditioned indoor laboratory setting with adequate ventilation.
- The noise level in the work environment is moderate.
- Frequent exposure to low temperatures in controlled refrigerators and/or freezers.
- Occasional exposure to biohazards, fumes and other airborne particles.