Investigation/CAPA Specialist
Humacao, PR · On-site
CAPA Management * Develop, implement, and track Corrective and Preventive Actions (CAPAs). * Evaluate CAPA effectiveness and sustainability. * Collaborate with cross-functional teams to ensure ...
Investigation/CAPA Specialist
Humacao, PR · On-site
CAPA Management * Develop, implement, and track Corrective and Preventive Actions (CAPAs). * Evaluate CAPA effectiveness and sustainability. * Collaborate with cross-functional teams to ensure ...
Investigation/CAPA Specialist
Humacao, PR · On-site
CAPA Management * Develop, implement, and track Corrective and Preventive Actions (CAPAs). * Evaluate CAPA effectiveness and sustainability. * Collaborate with cross-functional teams to ensure ...
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Investigation/CAPA Specialist
Humacao, PR · On-site
CAPA Management * Develop, implement, and track Corrective and Preventive Actions (CAPAs). * Evaluate CAPA effectiveness and sustainability. * Collaborate with cross-functional teams to ensure ...
Investigation/CAPA Specialist
Humacao, PR · On-site
CAPA Management * Develop, implement, and track Corrective and Preventive Actions (CAPAs). * Evaluate CAPA effectiveness and sustainability. * Collaborate with cross-functional teams to ensure ...
Investigation/CAPA Specialist
Humacao, PR · On-site
CAPA Management * Develop, implement, and track Corrective and Preventive Actions (CAPAs). * Evaluate CAPA effectiveness and sustainability. * Collaborate with cross-functional teams to ensure ...
Deviations Owner
Juncos, PR · On-site
Experience with deviation tracking systems, CAPA management, and electronic quality management systems (eQMS). * Excellent analytical, organizational, and problem-solving skills. * Strong ...
Deviations Owner
Juncos, PR · On-site
Experience with deviation tracking systems, CAPA management, and electronic quality management systems (eQMS). * Excellent analytical, organizational, and problem-solving skills. * Strong ...
PR · On-site
Investigations & CAPA Management: Lead and manage complex investigations, including root cause analysis for deviations. Develop and implement effective Corrective and Preventive Actions (CAPAs) to ...
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PR · On-site
Investigations & CAPA Management: Lead and manage complex investigations, including root cause analysis for deviations. Develop and implement effective Corrective and Preventive Actions (CAPAs) to ...
PR · On-site
$30 - $40/hr
Execute change controls, manage the associated documentation, and ensure all changes follow established GMP and regulatory procedures. * CAPA & Investigations: Complete CAPAs, support internal audits ...
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PR · On-site
$30 - $40/hr
Execute change controls, manage the associated documentation, and ensure all changes follow established GMP and regulatory procedures. * CAPA & Investigations: Complete CAPAs, support internal audits ...
Quality Manager
Juncos, PR · On-site
... Monitor CAPA implementation, closure timeliness, effectiveness, and sustainability. • Develop ... management. • Review and assess vendor performance trends, deviation patterns, and operational ...
Quality Manager
Juncos, PR · On-site
... Monitor CAPA implementation, closure timeliness, effectiveness, and sustainability. • Develop ... management. • Review and assess vendor performance trends, deviation patterns, and operational ...
Quality Manager
Juncos, PR · On-site
Manage and oversee minor and major deviations, investigations, root cause analysis, CAPAs, and ... Monitor CAPA implementation, closure timeliness, effectiveness, and sustainability. Develop ...
Quality Manager
Juncos, PR · On-site
Manage and oversee minor and major deviations, investigations, root cause analysis, CAPAs, and ... Monitor CAPA implementation, closure timeliness, effectiveness, and sustainability. Develop ...
PR · On-site
$40 - $50/hr
Change control, CAPA management, and audit readiness * Cross-functional coordination: Engineering, Quality, IT, Validation, Vendors * Capital Appropriation Request (CAR) management * Microsoft Office ...
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PR · On-site
$40 - $50/hr
Change control, CAPA management, and audit readiness * Cross-functional coordination: Engineering, Quality, IT, Validation, Vendors * Capital Appropriation Request (CAR) management * Microsoft Office ...
Sr Quality Operations Manager
Juncos, PR · On-site
The Senior Quality Operations Manager, Compliance & Audit engage in daily tier meetings and cross-functional forums - including CAPA Review Boards and Compliance Risk Burn Down sessions - where they ...
Sr Quality Operations Manager
Juncos, PR · On-site
The Senior Quality Operations Manager, Compliance & Audit engage in daily tier meetings and cross-functional forums - including CAPA Review Boards and Compliance Risk Burn Down sessions - where they ...
... CAPA management, process validation, and change control systems. • Familiarity with Lean Manufacturing principles and continuous improvement methodologies. • Experience with TrackWise, Veeva, MES ...
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... CAPA management, process validation, and change control systems. • Familiarity with Lean Manufacturing principles and continuous improvement methodologies. • Experience with TrackWise, Veeva, MES ...
PR · On-site
Understanding of quality systems, documentation practices, CAPA, and change management. * Strong organizational and communication skills. * Ability to work independently and within cross-functional ...
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PR · On-site
Understanding of quality systems, documentation practices, CAPA, and change management. * Strong organizational and communication skills. * Ability to work independently and within cross-functional ...
PR · On-site
Knowledge of ISO 9001 Quality Management Systems. * Experience handling CAPA processes, audits, and document control. * Knowledge of root cause analysis tools and methodologies. * Proficiency in ...
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PR · On-site
Knowledge of ISO 9001 Quality Management Systems. * Experience handling CAPA processes, audits, and document control. * Knowledge of root cause analysis tools and methodologies. * Proficiency in ...
PR · On-site
Understanding of quality systems, documentation practices, CAPA, and change management. * Strong organizational and communication skills. * Ability to work independently and within cross-functional ...
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PR · On-site
Understanding of quality systems, documentation practices, CAPA, and change management. * Strong organizational and communication skills. * Ability to work independently and within cross-functional ...
PR · On-site
This role is responsible for supporting investigations, CAPA activities, change management coordination, GMP documentation review, compliance tracking, and quality system support activities ...
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PR · On-site
This role is responsible for supporting investigations, CAPA activities, change management coordination, GMP documentation review, compliance tracking, and quality system support activities ...
PR · On-site
This role is responsible for supporting investigations, CAPA activities, change management coordination, GMP documentation review, compliance tracking, and quality system support activities ...
Quick apply
PR · On-site
This role is responsible for supporting investigations, CAPA activities, change management coordination, GMP documentation review, compliance tracking, and quality system support activities ...
PR · On-site
This role is responsible for supporting investigations, CAPA activities, change management coordination, GMP documentation review, compliance tracking, and quality system support activities ...
Quick apply
PR · On-site
This role is responsible for supporting investigations, CAPA activities, change management coordination, GMP documentation review, compliance tracking, and quality system support activities ...
PR · On-site
This role is responsible for supporting investigations, CAPA activities, change management coordination, GMP documentation review, compliance tracking, and quality system support activities ...
Quick apply
PR · On-site
This role is responsible for supporting investigations, CAPA activities, change management coordination, GMP documentation review, compliance tracking, and quality system support activities ...
PR · On-site
This role is responsible for supporting investigations, CAPA activities, change management coordination, GMP documentation review, compliance tracking, and quality system support activities ...
Quick apply
PR · On-site
This role is responsible for supporting investigations, CAPA activities, change management coordination, GMP documentation review, compliance tracking, and quality system support activities ...
PR · On-site
$35 - $45/hr
Change control and CAPA management * Cross-functional team coordination (Engineering, Quality, IT, Validation, Vendors) * Microsoft Office 365 -- Project, Excel, Word, Teams Soft Skills * Technical ...
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PR · On-site
$35 - $45/hr
Change control and CAPA management * Cross-functional team coordination (Engineering, Quality, IT, Validation, Vendors) * Microsoft Office 365 -- Project, Excel, Word, Teams Soft Skills * Technical ...
Capa Manager information
What does a CAPA Manager do?
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.
What are some common challenges a CAPA Manager faces, and how are they typically addressed?
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.
What is a CAPA manager?
A CAPA manager oversees the Corrective and Preventive Actions process within an organization to identify, investigate, and resolve quality issues or non-conformities. They ensure compliance with regulatory standards, often using quality management tools, and coordinate cross-functional teams to implement effective solutions.
What are the key skills and qualifications needed to thrive in the Capa Manager position, and why are they important?
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.
What job makes $10,000 a month without a degree?
A Capa Manager, or Corrective and Preventive Action Manager, can earn around $10,000 monthly by overseeing quality management systems in manufacturing or healthcare environments. Success in this role depends on experience, industry knowledge, and strong organizational skills, often without requiring a formal degree but emphasizing certifications and practical expertise.
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What job categories do people searching Capa Manager jobs in Puerto Rico look for? The top searched job categories for Capa Manager jobs in Puerto Rico are:
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Full-time
Posted 27 days ago
Job description
mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.
Position Overview
The Investigation / CAPA Specialists to support Quality Systems and Manufacturing Operations within a highly regulated medical device manufacturing environment. These resources will play a critical role supporting deviation investigations, nonconformance management, root cause analysis, CAPA development, and quality system compliance activities associated with manufacturing, engineering, and operational processes. The candidates will work cross-functionally with Manufacturing, Quality Assurance, Engineering, Supply Chain, and Operations teams to ensure timely closure of investigations and implementation of sustainable corrective and preventive actions aligned with FDA and ISO regulatory expectations.
Key Responsibilities
Investigations & Quality Events
Position Overview
The Investigation / CAPA Specialists to support Quality Systems and Manufacturing Operations within a highly regulated medical device manufacturing environment. These resources will play a critical role supporting deviation investigations, nonconformance management, root cause analysis, CAPA development, and quality system compliance activities associated with manufacturing, engineering, and operational processes. The candidates will work cross-functionally with Manufacturing, Quality Assurance, Engineering, Supply Chain, and Operations teams to ensure timely closure of investigations and implementation of sustainable corrective and preventive actions aligned with FDA and ISO regulatory expectations.
Key Responsibilities
Investigations & Quality Events
- Lead and support investigations related to:
- Nonconformances (NCs)
- Deviations
- CAPAs
- Customer complaints
- Manufacturing events
- Process excursions
- Equipment and documentation discrepancies
- Perform detailed root cause analysis using methodologies (such as...5 Whys, Fishbone / Ishikawa, Fault Tree Analysis, Risk Assessments, Trend Analysis ...)
- Ensure investigations are properly documented, technically justified, and closed within established timelines.
- Develop, implement, and track Corrective and Preventive Actions (CAPAs).
- Evaluate CAPA effectiveness and sustainability.
- Collaborate with cross-functional teams to ensure corrective actions address systemic issues.
- Monitor CAPA metrics and identify recurring trends impacting quality performance.
- Author and review investigation reports, CAPA records, technical assessments, and quality documentation.
- Support documentation activities within electronic quality management systems (eQMS).
- Ensure compliance
- Support audit readiness initiatives and participate in internal/external audits.
- Partner with Manufacturing, Engineering, Validation, and Operations teams to evaluate process impact and implement corrective strategies.
- Participate in risk assessments and continuous improvement initiatives.
- Support escalation meetings and quality review boards when required.
- Provide technical support during regulatory inspections and quality audits.
- Bachelor's Degree in: Engineering, Chemistry, Microbiology, Life Sciences, Industrial Sciences or Related Technical Discipline.
- Minimum:
- 3 - 5 years of experience
- Experience in Medical Device, Pharmaceutical, Biotechnology and FDA-regulated manufacturing environments.
- Strong experience managing: Investigations, Deviations, Nonconformances and CAPA systems.
- Hands-on experience with root cause analysis methodologies.
- Experience using quality systems such as: TrackWise, Infinity, SAP, MasterControl, ETQ or Similar eQMS platforms.
- Knowledge of: FDA regulations, ISO 13485, GMP requirements and Data Integrity principles.
- Strong technical writing and documentation skills.
- Experience supporting audit readiness and inspection support activities.
- Root Cause Analysis
- CAPA Management
- Investigation Writing
- Nonconformance Management
- Quality Systems
- GMP Compliance
- Risk Assessments
- Technical Documentation
- Problem Solving
- Cross-Functional Coordination
- Data Trending & Analysis