Rochester, NY · Hybrid
$110K - $138K/yr
Perform site management activities to support the client's Oncology site success and maintain a ... CAPA) plans * Deliver training to ensure sites comply with the protocol, Standard Operating ...
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Rochester, NY · Hybrid
$110K - $138K/yr
Perform site management activities to support the client's Oncology site success and maintain a ... CAPA) plans * Deliver training to ensure sites comply with the protocol, Standard Operating ...
Victor, NY · On-site
... CAPA) are implemented in support of the Quality Management System. * Develop and implement new tools to deliver commodity process efficiencies REQUIRED QUALIFICATIONS: * Minimum of 5 years of Supply ...
Victor, NY · On-site
... CAPA) are implemented in support of the Quality Management System. * Develop and implement new tools to deliver commodity process efficiencies REQUIRED QUALIFICATIONS: * Minimum of 5 years of Supply ...
... CAPA) are implemented in support of the Quality Management System. * Develop and implement new tools to deliver commodity process efficiencies REQUIRED QUALIFICATIONS: * Minimum of 5 years of Supply ...
... CAPA) are implemented in support of the Quality Management System. * Develop and implement new tools to deliver commodity process efficiencies REQUIRED QUALIFICATIONS: * Minimum of 5 years of Supply ...
DUTIES / RESPONSIBILITIES Deviations and CAPA Support and provide final review and approval of ... Manage CAPAs associated with deviations, customer complaints, and audit observations using ...
DUTIES / RESPONSIBILITIES Deviations and CAPA Support and provide final review and approval of ... Manage CAPAs associated with deviations, customer complaints, and audit observations using ...
May assist management with review and approval of corrective and preventative action (CAPA , Nonconformance Reports (NCR), and Quality Feedbacks (QFB)). * May assist with process audits to verify ...
May assist management with review and approval of corrective and preventative action (CAPA , Nonconformance Reports (NCR), and Quality Feedbacks (QFB)). * May assist with process audits to verify ...
Rochester, NY · On-site
Familiarity with CAPA, nonconformance management, and corrective action processes. Experience with document control systems, quality databases, and quality data analysis tools. Strong analytical ...
New
Rochester, NY · On-site
Familiarity with CAPA, nonconformance management, and corrective action processes. Experience with document control systems, quality databases, and quality data analysis tools. Strong analytical ...
New
Rochester, NY · On-site
Familiarity with CAPA, nonconformance management, and corrective action processes. * Experience with document control systems, quality databases, and quality data analysis tools. * Strong analytical ...
Rochester, NY · On-site
Familiarity with CAPA, nonconformance management, and corrective action processes. * Experience with document control systems, quality databases, and quality data analysis tools. * Strong analytical ...
Victor, NY · On-site
$22.70 - $30.27/hr
May assist management with review and approval of corrective and preventative action (CAPA , Nonconformance Reports (NCR), and Quality Feedbacks (QFB)). * May assist with process audits to verify ...
Victor, NY · On-site
$22.70 - $30.27/hr
May assist management with review and approval of corrective and preventative action (CAPA , Nonconformance Reports (NCR), and Quality Feedbacks (QFB)). * May assist with process audits to verify ...
Fairport, NY · On-site
$98K - $127K/yr
... CAPA) * Mentor and coach peers and early career engineers * Perform duties in accordance with ... CAPEX project management experience. * Driven to get results and make impactful changes.
Fairport, NY · On-site
$98K - $127K/yr
... CAPA) * Mentor and coach peers and early career engineers * Perform duties in accordance with ... CAPEX project management experience. * Driven to get results and make impactful changes.
Rochester, NY · On-site
$23 - $28/hr
Ensure compliance with ISO 13485, MDSAP, FDA regulations, and internal quality system requirements while supporting audits, CAPA activities, change control, and risk management processes. * Less than ...
Rochester, NY · On-site
$23 - $28/hr
Ensure compliance with ISO 13485, MDSAP, FDA regulations, and internal quality system requirements while supporting audits, CAPA activities, change control, and risk management processes. * Less than ...
Fairport, NY · On-site
Partner with Quality to support CAPA, PFMEA, control plans, and process validation activities ... Strong analytical, problem-solving, and project management skills. * Excellent communication and ...
Fairport, NY · On-site
Partner with Quality to support CAPA, PFMEA, control plans, and process validation activities ... Strong analytical, problem-solving, and project management skills. * Excellent communication and ...
Fairport, NY · On-site
$68K - $88K/yr
Verification, Validation & Risk Management: * Support verification and validation (V&V) planning in ... Support root cause analysis and corrective and preventive actions (CAPA) to address quality issues ...
Fairport, NY · On-site
$68K - $88K/yr
Verification, Validation & Risk Management: * Support verification and validation (V&V) planning in ... Support root cause analysis and corrective and preventive actions (CAPA) to address quality issues ...
Fairport, NY · On-site
$68K - $88K/yr
Verification, Validation & Risk Management: * Support verification and validation (V&V) planning in ... Support root cause analysis and corrective and preventive actions (CAPA) to address quality issues ...
Fairport, NY · On-site
$68K - $88K/yr
Verification, Validation & Risk Management: * Support verification and validation (V&V) planning in ... Support root cause analysis and corrective and preventive actions (CAPA) to address quality issues ...
Fairport, NY · On-site
$68K - $88K/yr
Verification, Validation & Risk Management: * Support verification and validation (V&V) planning in ... Support root cause analysis and corrective and preventive actions (CAPA) to address quality issues ...
Fairport, NY · On-site
$68K - $88K/yr
Verification, Validation & Risk Management: * Support verification and validation (V&V) planning in ... Support root cause analysis and corrective and preventive actions (CAPA) to address quality issues ...
Rochester, NY · On-site
$23 - $28/hr
Ensure compliance with ISO 13485, MDSAP, FDA regulations, and internal quality system requirements while supporting audits, CAPA activities, change control, and risk management processes. * Less than ...
Rochester, NY · On-site
$23 - $28/hr
Ensure compliance with ISO 13485, MDSAP, FDA regulations, and internal quality system requirements while supporting audits, CAPA activities, change control, and risk management processes. * Less than ...
Rochester, NY · On-site
$27.47 - $34.34/hr
Reports all unsafe situations and conditions to management. * Maintains/stocks adequate inventory ... CAPA implementations and continuous improvement initiatives). * Assists with storage room ...
Rochester, NY · On-site
$27.47 - $34.34/hr
Reports all unsafe situations and conditions to management. * Maintains/stocks adequate inventory ... CAPA implementations and continuous improvement initiatives). * Assists with storage room ...
Rochester, NY · On-site
$27.47 - $34.34/hr
Reports all unsafe situations and conditions to management. * Maintains/stocks adequate inventory ... CAPA implementations and continuous improvement initiatives). * Assists with storage room ...
Rochester, NY · On-site
$27.47 - $34.34/hr
Reports all unsafe situations and conditions to management. * Maintains/stocks adequate inventory ... CAPA implementations and continuous improvement initiatives). * Assists with storage room ...
Rochester, NY · On-site
$31.63 - $39.53/hr
Reports all unsafe situations and conditions to management. * Maintains/stocks adequate inventory ... CAPA implementations and continuous improvement initiatives). * Assists with storage room ...
Rochester, NY · On-site
$31.63 - $39.53/hr
Reports all unsafe situations and conditions to management. * Maintains/stocks adequate inventory ... CAPA implementations and continuous improvement initiatives). * Assists with storage room ...
Rochester, NY · On-site
$31.63 - $39.53/hr
Reports all unsafe situations and conditions to management. * Maintains/stocks adequate inventory ... CAPA implementations and continuous improvement initiatives). * Assists with storage room ...
Rochester, NY · On-site
$31.63 - $39.53/hr
Reports all unsafe situations and conditions to management. * Maintains/stocks adequate inventory ... CAPA implementations and continuous improvement initiatives). * Assists with storage room ...
Rochester, NY · On-site
... performance observations, CAPA implementations and continuous improvement initiatives ... Managers who truly want you to grow and excel. * Formal training * Outstanding plans for medical ...
Rochester, NY · On-site
... performance observations, CAPA implementations and continuous improvement initiatives ... Managers who truly want you to grow and excel. * Formal training * Outstanding plans for medical ...
$12.81 - $16.63
2% of jobs
$16.63 - $20.45
5% of jobs
$20.45 - $24.26
8% of jobs
$24.26 - $28.08
8% of jobs
$28.51 is the 25th percentile. Wages below this are outliers.
$28.08 - $31.90
9% of jobs
$31.90 - $35.72
8% of jobs
The median wage is $38.50 / hr.
$35.72 - $39.54
11% of jobs
$39.54 - $43.36
21% of jobs
$43.64 is the 75th percentile. Wages above this are outliers.
$43.36 - $47.18
15% of jobs
$47.18 - $51
6% of jobs
$51 - $54.82
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.
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.
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.
For Capa Manager jobs in Rochester, NY, the most frequently searched job titles are:
The top searched job categories for Capa Manager jobs in Rochester, NY are:
Cities near Rochester, NY with the most Capa Manager job openings:
Rochester, NY • Hybrid
$110K - $138K/yr
Full-time
Medical, Dental, Vision, Life, Retirement
Re-posted 17 days ago
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
Responsibilities:
Perform site management activities to support the client's Oncology site success and maintain a continuous state of inspection readiness
Act as the primary contact and facilitate efficient communications between the client's clinical trial team and the sites
Perform remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in the client's trials
May perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs
Promptly document monitoring activities and submit/approve visit reports
Manage site essential document collection and TMF reconciliation with site files
Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals
Regularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolution
Independently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans
Deliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations
Support sites and the client's regulatory inspections
Contribute to site identification; drive site feasibility and qualification progress; and support site activation activities
Lead site engagement initiatives and foster relationships with key Oncology sites and networks
Qualifications
Bachelor’s degree (scientific field preferred)
5+ years monitoring clinical trials independently conducting on-site and remote monitoring visits. Atleast 2 years monitoring solid tumor clinical trials.
1+ years early development trial experience
Solid tumor clinical trial experience is required
Experience utilizing Veeva systems is highly preferred
Demonstrated experience developing/maintaining site relationships and securing compliance
Expertise in GxPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminology
Experience collaborating with sites from initial engagement through close-out phases
Experience activating sites
Experience training site staff
Experience supporting sites and/or sponsors in regulatory inspections
Experience working within a Functional Services (or in-house) monitoring model is preferred
Willing to travel up to 50%
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Salary Range
$110,520.00-$138,150.00Are you a current ICON Employee? Please click here to apply
