Provides leadership and/or represents Quality Systems on Client Corporate improvement teams focused on CAPA Management. Represents Client on the Corporate CAPA Expertise Council. Responsible for ...
Provides leadership and/or represents Quality Systems on Client Corporate improvement teams focused on CAPA Management. Represents Client on the Corporate CAPA Expertise Council. Responsible for ...
QA CAPA Engineer II
Bedford, MA · On-site
$66K - $88K/yr
Support activities within the Quality Management System as required REQUIREMENTS How will you get ... Knowledge of TrackWise CAPA Management System is a plus. * Must maintain high ethical standards to ...
QA CAPA Engineer II
Bedford, MA · On-site
$66K - $88K/yr
Support activities within the Quality Management System as required REQUIREMENTS How will you get ... Knowledge of TrackWise CAPA Management System is a plus. * Must maintain high ethical standards to ...
QA CAPA Engineer II
$66K - $88K/yr
Support activities within the Quality Management System as required REQUIREMENTS How will you get ... Knowledge of TrackWise CAPA Management System is a plus. * Must maintain high ethical standards to ...
QA CAPA Engineer II
$66K - $88K/yr
Support activities within the Quality Management System as required REQUIREMENTS How will you get ... Knowledge of TrackWise CAPA Management System is a plus. * Must maintain high ethical standards to ...
Manager, Clinical Quality Assurance
Waltham, MA · On-site +1
$135K - $149K/yr
Oversee and/or Conduct other GCP related audits as indicated (e.g. metrics, deviation/CAPA management, etc.) Collaborate with internal teams to support deviation management activities, including ...
Manager, Clinical Quality Assurance
Waltham, MA · On-site +1
$135K - $149K/yr
Oversee and/or Conduct other GCP related audits as indicated (e.g. metrics, deviation/CAPA management, etc.) Collaborate with internal teams to support deviation management activities, including ...
Corrective and Preventive Action (CAPA) * Management Review support * Ensure QMS processes are established, implemented, maintained, and effective in accordance with ISO and company requirements.
Corrective and Preventive Action (CAPA) * Management Review support * Ensure QMS processes are established, implemented, maintained, and effective in accordance with ISO and company requirements.
Quality Systems Manager
Chelmsford, MA · On-site
CAPA Program Leadership Serve as the site CAPA leader, overseeing the end-to-end Corrective and ... Experience managing audits, CAPA programs, document control systems, training programs, and quality ...
Quality Systems Manager
Chelmsford, MA · On-site
CAPA Program Leadership Serve as the site CAPA leader, overseeing the end-to-end Corrective and ... Experience managing audits, CAPA programs, document control systems, training programs, and quality ...
Quality Systems Manager
Chelmsford, MA · On-site
CAPA Program Leadership • Serve as the site CAPA leader, overseeing the end-to-end Corrective and ... analyses, and management reports. • Compile, maintain, and communicate quality metrics and ...
Quality Systems Manager
Chelmsford, MA · On-site
CAPA Program Leadership • Serve as the site CAPA leader, overseeing the end-to-end Corrective and ... analyses, and management reports. • Compile, maintain, and communicate quality metrics and ...
Lead reviews for new system implementations, upgrades, and releases, including deviation and CAPA management. * Support data integrity assessments, change control, and system testing oversight.
Lead reviews for new system implementations, upgrades, and releases, including deviation and CAPA management. * Support data integrity assessments, change control, and system testing oversight.
Design Quality Engineer (DQE)-Andover, MA
Andover, MA · On-site
$72K - $94K/yr
Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes
Quick apply
Design Quality Engineer (DQE)-Andover, MA
Andover, MA · On-site
$72K - $94K/yr
Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes
System Test and Validation Lead
Boston, MA · On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Boston, MA · On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Boston, MA · On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Boston, MA · On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Boston, MA · On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Boston, MA · On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
Deviation, Investigation, and CAPA Management * Lead or support deviation triage, investigation, root cause analysis, impact assessments, and CAPA development . * Ensure quality issues are documented ...
Deviation, Investigation, and CAPA Management * Lead or support deviation triage, investigation, root cause analysis, impact assessments, and CAPA development . * Ensure quality issues are documented ...
Design Quality Engineer
Andover, MA · On-site
Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes Key Responsibilities * Serving as the quality lead on product development teams, ensuring compliance with design ...
Quick apply
Design Quality Engineer
Andover, MA · On-site
Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes Key Responsibilities * Serving as the quality lead on product development teams, ensuring compliance with design ...
Deviation, Investigation, and CAPA Management * Lead or support deviation triage, investigation, root cause analysis, impact assessments, and CAPA development . * Ensure quality issues are documented ...
Deviation, Investigation, and CAPA Management * Lead or support deviation triage, investigation, root cause analysis, impact assessments, and CAPA development . * Ensure quality issues are documented ...
Vendor Quality Manager
Boston, MA · On-site
Support investigation, CAPA, change control, and supplier quality management activities. Skills Required * Vendor Quality Management * Supplier Quality Management * GMP (Good Manufacturing Practices)
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Vendor Quality Manager
Boston, MA · On-site
Support investigation, CAPA, change control, and supplier quality management activities. Skills Required * Vendor Quality Management * Supplier Quality Management * GMP (Good Manufacturing Practices)
Lead management review processes and oversee CAPA effectiveness. * Serve as a subject matter expert in quality processes, offering real-time problem solving and guidance. * Review and approve key ...
Lead management review processes and oversee CAPA effectiveness. * Serve as a subject matter expert in quality processes, offering real-time problem solving and guidance. * Review and approve key ...
CAPA development and management * Audit and inspection readiness including development of auditing and monitoring tools and procedures * Ability to independently drive results with urgency and ...
New
CAPA development and management * Audit and inspection readiness including development of auditing and monitoring tools and procedures * Ability to independently drive results with urgency and ...
New
CAPA development and management * Audit and inspection readiness including development of auditing and monitoring tools and procedures * Ability to independently drive results with urgency and ...
New
CAPA development and management * Audit and inspection readiness including development of auditing and monitoring tools and procedures * Ability to independently drive results with urgency and ...
New
Senior Manager, Clinical Study Quality Lead (Hybrid)
Boston, MA · On-site
$137K - $206K/yr
General Summary: The Senior Manager, Clinical Study Quality Lead provides study-level quality ... Review audit reports, responses, and CAPA plans to ensure findings are appropriately assessed ...
Senior Manager, Clinical Study Quality Lead (Hybrid)
Boston, MA · On-site
$137K - $206K/yr
General Summary: The Senior Manager, Clinical Study Quality Lead provides study-level quality ... Review audit reports, responses, and CAPA plans to ensure findings are appropriately assessed ...
Capa Manager information
What is the role of a Capa specialist?
A CAPA (Corrective and Preventive Action) specialist is responsible for investigating quality issues, implementing corrective actions, and preventing recurrence of problems within a quality management system. They analyze data, ensure compliance with regulations, and often use tools like root cause analysis to improve product and process quality.
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 is a capa coordinator?
A CAPA (Corrective and Preventive Action) coordinator is responsible for managing and overseeing the CAPA process within a quality management system. They investigate quality issues, implement corrective actions, and ensure compliance with regulatory standards, often using tools like root cause analysis and tracking software. This role requires strong organizational skills and knowledge of quality regulations such as ISO or FDA requirements.
What is the highest paying manager position?
The highest paying manager positions are typically executive roles such as Chief Executive Officer (CEO), Chief Operating Officer (COO), and Chief Financial Officer (CFO), which often have salaries exceeding several hundred thousand dollars annually. In some industries, specialized managerial roles like Vice President or Director of certain departments can also command high compensation, especially with bonuses and stock options included.
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 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 does a capa manager do?
A CAPA (Corrective and Preventive Action) manager oversees the implementation of processes to identify, investigate, and resolve quality issues within an organization. They analyze root causes, develop action plans, and ensure compliance with regulatory standards, often using quality management systems and tools like CAPA software. The role requires strong problem-solving skills and knowledge of industry regulations such as ISO or FDA standards.
What job categories do people searching Capa Manager jobs in Saugus, MA look for? The top searched job categories for Capa Manager jobs in Saugus, MA are:
What cities near Saugus, MA are hiring for Capa Manager jobs? Cities near Saugus, MA with the most Capa Manager job openings:
Contractor
Re-posted 29 days ago
Job description
Company Description
Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.
Job Description
About Client:
Client is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Equal Employment Opportunity
Client is an equal opportunity employer. Client evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic
Responsible for supporting the development, deployment, maintenance, and improvement of the Corrective Action and Preventive Action (CAPA) Management processes and procedures within Client. Ensures effective deployment of CAPA requirements (both internal and external) into the division and corporate procedures. Provides leadership and/or represents Quality Systems on Client Corporate improvement teams focused on CAPA Management. Represents Client on the Corporate CAPA Expertise Council. Responsible for results in terms of conformance to global GMP regulations and Client quality policies and standards.
Responsibilities:
- Supports the Quality Lead for Deviations/CAPA as a Subject Matter Expert (SME) for the Client Global Event Management Systems (GEMS, Current and Legacy systems)
- Supports GEMS process and closure of legacy Client processes.
- Supports GEMS and legacy Client system metrics
- Responsible for supporting global event management processes and procedures (and others as necessary), by working with cross-functional working teams to develop and deploy CAPA processes that are standardized across Client and leverage best practices for business efficiency.
- Manages Client's GEMS Expertise Council related to Legacy Client GEMS that is comprised of Network Event Coaches from each of the Network Event Review Boards (Plasma, Recombinant, Small Molecule, BioLife, and Distribution). Supports maintenance of an effective connectivity and related mechanisms among the Network Event Review Boards and Investigation teams. Supports customer feedback and system enhancements/ corrections.
- Responsible for preparing and providing training and/or supporting corporate and facility training for the GEMS procedures as developed.
- Maintains expertise in event/deviation management through ongoing training and participation in industry associations.
- Understands and assures conformance to Global GMP requirements and regulations. Interfaces with regulators during regulatory inspections.
- Support integration of Deviation/CAPA systems as required by management.
Qualifications
Education & Experience Requirements:
Essential:
- Minimum of a Bachelor's degree in a science related field plus 5 years quality experience in deviation systems
Desired:
- ASQ Certified Quality Manager
- Experience with Medical Devices, Biologics, Blood Products, and small molecules
- Six Sigma Black or Green belt certified
Additional Information
Kind Regards,
Sasha Sharma
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
DIRECT # - 732-662-7964
About Integrated Resources
Sourced by ZipRecruiter
Integrated Resources Inc (IRI), based in Edison, NJ, US, is an esteemed player in the staffing solutions industry with a credible presence on their official website irionline.com. Notably, IRI provides a range of professional staffing services including contract, contract-to-hire, and direct hire solutions to a wide spectrum of industries such as healthcare, life sciences, manufacturing, financial, insurance, and others. Since its inception, IRI has been committed to delivering top-talent and optimum solutions to meet its clients' diverse needs.
Industry
Recruiting and staffing services
Company size
51 - 200 Employees
Headquarters location
Edison, NJ, US
Year founded
1996