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Capa Manager Jobs in Connecticut (NOW HIRING)

SCA Pharma

Validation Engineer

Windsor, CT · On-site

Manage a schedule for outsourcing HEPA Filter recertification. Oversee and approve the outsourced ... Drive CAPA's assigned to the validation department * Generate and approve SCA Certificate of ...

DURHAM Manufacturing

Engineer Manager

Durham, CT · On-site

$90K - $150K/yr

... actions, CAPA initiatives, and process improvementsMaintain engineering documentation and support document control standardsWhat We're Looking ForBachelor's degree in Mechanical Engineering ...

ImageTek Mfg., Inc.

Assistant Quality Manager

Putnam, CT · On-site

$55K - $75K/yr

As Assistant Quality Manager, you will help support the overall health and effectiveness of the ... At times, lead or coordinate Corrective and Preventive Actions (CAPA). * Help identify trends and ...

Adecco

Plant Manager

Windsor, CT

The Plant Manager will oversee operations across our two Connecticut manufacturing locations in ... Drive corrective and preventive actions (CAPA/RCCA) and continuous quality improvement * Maintain ...

Adecco

Plant Manager

Windsor, CT

The Plant Manager will oversee operations across our two Connecticut manufacturing locations in ... Drive corrective and preventive actions (CAPA/RCCA) and continuous quality improvement * Maintain ...

Bio-Techne

Manager, Quality

Wallingford, CT · On-site

$91K - $150K/yr

Position will manage the Quality Management System activities of Bio-Techne's Wallingford site, including but not limited to document control, training, validations, CAPA, NCMRs and deviations among ...

Bio-Techne

Manager, Quality

Wallingford, CT · On-site

$91K - $150K/yr

Position will manage the Quality Management System activities of Bio-Techne's Wallingford site, including but not limited to document control, training, validations, CAPA, NCMRs and deviations among ...

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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 the key skills and qualifications needed to thrive as a CAPA manager?

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 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 job categories do people searching Capa Manager jobs in Connecticut look for?

The top searched job categories for Capa Manager jobs in Connecticut are:

What cities in Connecticut are hiring for Capa Manager jobs?

Cities in Connecticut with the most Capa Manager job openings:

Capa Manager jobs near you

Validation Engineer

SCA Pharma

Windsor, CT • On-site

Full-time

Posted 22 days ago

Job description

SCA Pharmaceuticals is a dynamic rapidly growing company consisting of passionate individuals who believe in our mission of providing high quality medications that are critical in saving and sustaining human life. SCA Pharma is an FDA 503B outsourcing facility providing customized medications for hospitals and healthcare facilities across the United States. We do this through unyielding quality, safety and integrity, our commitment to accountability and ownership, teamwork and creating better solutions by simplifying the complex.
Summary:
The Validation Engineer oversees the aseptic process simulations (media fills), equipment qualification and requalification, facility and utility qualification and requalification. This position supports Operations and Quality and will maintain a compliant schedule of validation activities and will serve as a technical resource in process improvement initiatives that require a validation expertise.
Essential functions:
  • Execute validation and qualification activities (equipment, media fills, facility, utility, environmental monitoring system) to include protocol preparation, scheduling execution, protocol execution, and final report preparation.
  • Ensure that C&Q and Validation project deliverables (i.e., Specification, SOPs; Protocols/Reports; Risk Assessment; Traceability Matrix, etc.) are compliant with the current regulations, current industry practices, and internal policies and procedures.
  • Maintain a revalidation / requalification lifecycle and executes accordingly per Standard Operating Procedures (SOPs).
  • Execute airflow patterns (smoke studies) of compounding operations.
  • Manage a schedule for outsourcing HEPA Filter recertification. Oversee and approve the outsourced activities.
  • Effectively coordinate and communicate all due validation/qualification activities with relevant functional groups to enable compliance to the validation / qualification schedule.
  • Develops/improves validation and qualification programs as needed to remain current with cGMP's and industry standards.
  • Represent validation in teams assembled to procure, install, troubleshoot systems, equipment, and processes.
  • Conduct and/or participate in deviation investigations as appropriate to identify root causes and define corrective and/or preventative actions (CAPA).
  • Drive CAPA's assigned to the validation department
  • Generate and approve SCA Certificate of Compliance

Requirements
Required Qualifications & Experience:
  • Bachelor's degree in life sciences, engineering, or related discipline.
  • 5+ years of direct validation experience in pharmaceutical and/or life sciences.

Desired Knowledge, Skills, and Abilities:
  • Proficient in MS Word, Excel, and PowerPoint
  • Have effective communication (both written and verbal).
  • Demonstrated strong technical writing skills, decision making abilities and critical thinking.
  • Demonstrated knowledge and understanding of cGMP's, industry guidance associated with aseptic processing, CAPA, root-cause analysis, risk assessment and investigation tools and techniques.
  • Knowledge and experience in leading aseptic process simulations (media fills)

SCA Pharma is an equal opportunity employer (Minorities/Females/Disabled/Veterans). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state, or local law.

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