This role is responsible for batch record review and lot release, as well as driving robust deviation investigations and CAPA management to maintain product sterility assurance and regulatory ...
This role is responsible for batch record review and lot release, as well as driving robust deviation investigations and CAPA management to maintain product sterility assurance and regulatory ...
We are seeking an experienced Quality Manager to lead and continuously improve our Quality ... Drive corrective and preventive actions (CAPA) and respond to customer complaints * Partner with ...
We are seeking an experienced Quality Manager to lead and continuously improve our Quality ... Drive corrective and preventive actions (CAPA) and respond to customer complaints * Partner with ...
... CAPA's (including verification of CAPA's) and other quality documents as needed. * Manage and ... maintain audit inspections (Internal and External) for the site. * Responsible for supporting the ...
... CAPA's (including verification of CAPA's) and other quality documents as needed. * Manage and ... maintain audit inspections (Internal and External) for the site. * Responsible for supporting the ...
... CAPA's (including verification of CAPA's) and other quality documents as needed. * Manage and ... maintain audit inspections (Internal and External) for the site. * Responsible for supporting the ...
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... CAPA's (including verification of CAPA's) and other quality documents as needed. * Manage and ... maintain audit inspections (Internal and External) for the site. * Responsible for supporting the ...
... CAPA's (including verification of CAPA's) and other quality documents as needed. * Manage and ... maintain audit inspections (Internal and External) for the site. * Responsible for supporting the ...
... CAPA's (including verification of CAPA's) and other quality documents as needed. * Manage and ... maintain audit inspections (Internal and External) for the site. * Responsible for supporting the ...
Quality Manager
South Hill, VA · On-site
Own and manage CAPA processes, ensuring corrective actions are effective and sustainable * Develop and implement scrap reduction plans, including tracking, analysis, and reporting of key quality ...
Quality Manager
South Hill, VA · On-site
Own and manage CAPA processes, ensuring corrective actions are effective and sustainable * Develop and implement scrap reduction plans, including tracking, analysis, and reporting of key quality ...
Own and manage CAPA processes, ensuring corrective actions are effective and sustainable * Develop and implement scrap reduction plans, including tracking, analysis, and reporting of key quality ...
Own and manage CAPA processes, ensuring corrective actions are effective and sustainable * Develop and implement scrap reduction plans, including tracking, analysis, and reporting of key quality ...
Manage nonconformance reporting and disposition processes ... Corrective and Preventive Actions (CAPA): * Lead root cause analysis investigations. * Implement ...
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Manage nonconformance reporting and disposition processes ... Corrective and Preventive Actions (CAPA): * Lead root cause analysis investigations. * Implement ...
QA Manager
Salem, VA · On-site
$75K - $100K/yr
As the site Quality Assurance Manager, you will play a vital role in the PharmaLogic quality ... Initiate and complete CAPA investigation as deemed necessary and report results and trends.
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QA Manager
Salem, VA · On-site
$75K - $100K/yr
As the site Quality Assurance Manager, you will play a vital role in the PharmaLogic quality ... Initiate and complete CAPA investigation as deemed necessary and report results and trends.
Quality Manager
Chester, VA · On-site
$118K - $178K/yr
We are seeking a Quality Manager with proven experience in chemical manufacturing to lead our ... Experience with customer complaint handling and CAPA systems in a regulated environment.
Quality Manager
Chester, VA · On-site
$118K - $178K/yr
We are seeking a Quality Manager with proven experience in chemical manufacturing to lead our ... Experience with customer complaint handling and CAPA systems in a regulated environment.
Quality Manager
$118K - $178K/yr
We are seeking a Quality Manager with proven experience in chemical manufacturing to lead our ... Experience with customer complaint handling and CAPA systems in a regulated environment.
Quality Manager
$118K - $178K/yr
We are seeking a Quality Manager with proven experience in chemical manufacturing to lead our ... Experience with customer complaint handling and CAPA systems in a regulated environment.
OneSource Account Quality Specialist
$80K - $90K/yr
Track audit findings, non-conformances, and CAPA effectiveness Deviation, CAPA & Change Control ... Strong working knowledge of Quality Management Systems in GxP environments * Proficiency in ...
OneSource Account Quality Specialist
$80K - $90K/yr
Track audit findings, non-conformances, and CAPA effectiveness Deviation, CAPA & Change Control ... Strong working knowledge of Quality Management Systems in GxP environments * Proficiency in ...
OneSource Account Quality Specialist
Richmond, VA · On-site
$80K - $90K/yr
Track audit findings, non-conformances, and CAPA effectiveness Deviation, CAPA & Change Control ... Strong working knowledge of Quality Management Systems in GxP environments * Proficiency in ...
OneSource Account Quality Specialist
Richmond, VA · On-site
$80K - $90K/yr
Track audit findings, non-conformances, and CAPA effectiveness Deviation, CAPA & Change Control ... Strong working knowledge of Quality Management Systems in GxP environments * Proficiency in ...
OneSource Account Quality Specialist
Richmond, VA · On-site
$80K - $90K/yr
Track audit findings, non-conformances, and CAPA effectiveness Deviation, CAPA & Change Control ... Strong working knowledge of Quality Management Systems in GxP environments * Proficiency in ...
OneSource Account Quality Specialist
Richmond, VA · On-site
$80K - $90K/yr
Track audit findings, non-conformances, and CAPA effectiveness Deviation, CAPA & Change Control ... Strong working knowledge of Quality Management Systems in GxP environments * Proficiency in ...
Manage corrective and preventive action (CAPA) processes, including root-cause analysis and verification of effectiveness. * Support readiness for customer reviews, inspections, and audits ...
Manage corrective and preventive action (CAPA) processes, including root-cause analysis and verification of effectiveness. * Support readiness for customer reviews, inspections, and audits ...
EHS Manager (GMP experience required)
Chantilly, VA · On-site
$85K - $116K/yr
Investigate incidents, near-misses, and safety concerns; implement corrective and preventive actions (CAPA) * Oversee chemical safety, hazardous material handling, waste management, and emergency ...
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EHS Manager (GMP experience required)
Chantilly, VA · On-site
$85K - $116K/yr
Investigate incidents, near-misses, and safety concerns; implement corrective and preventive actions (CAPA) * Oversee chemical safety, hazardous material handling, waste management, and emergency ...
EHS Manager (GMP experience required)
Chantilly, VA · On-site
$85K - $116K/yr
Investigate incidents, near-misses, and safety concerns; implement corrective and preventive actions (CAPA) * Oversee chemical safety, hazardous material handling, waste management, and emergency ...
EHS Manager (GMP experience required)
Chantilly, VA · On-site
$85K - $116K/yr
Investigate incidents, near-misses, and safety concerns; implement corrective and preventive actions (CAPA) * Oversee chemical safety, hazardous material handling, waste management, and emergency ...
EHS Manager (GMP experience required)
Chantilly, VA · On-site
$85K - $116K/yr
Investigate incidents, near-misses, and safety concerns; implement corrective and preventive actions (CAPA) * Oversee chemical safety, hazardous material handling, waste management, and emergency ...
EHS Manager (GMP experience required)
Chantilly, VA · On-site
$85K - $116K/yr
Investigate incidents, near-misses, and safety concerns; implement corrective and preventive actions (CAPA) * Oversee chemical safety, hazardous material handling, waste management, and emergency ...
Continuous Improvement Manager
Norfolk, VA · On-site
$91K - $122K/yr
Partner with Quality teams to reduce defect rates, CAPA recurrence, and manufacturing variation ... Project Management * Plan, execute, and sustain medium-to-large scale CI projects, ensuring ...
Continuous Improvement Manager
Norfolk, VA · On-site
$91K - $122K/yr
Partner with Quality teams to reduce defect rates, CAPA recurrence, and manufacturing variation ... Project Management * Plan, execute, and sustain medium-to-large scale CI projects, ensuring ...
Continuous Improvement Manager
Norfolk, VA · On-site
$82K - $110K/yr
Partner with Quality teams to reduce defect rates, CAPA recurrence, and manufacturing variation ... Project Management * Plan, execute, and sustain medium‑to‑large scale CI projects, ensuring ...
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Continuous Improvement Manager
Norfolk, VA · On-site
$82K - $110K/yr
Partner with Quality teams to reduce defect rates, CAPA recurrence, and manufacturing variation ... Project Management * Plan, execute, and sustain medium‑to‑large scale CI projects, ensuring ...
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 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.

Full-time
Posted 21 days ago
Job description
We invite you to explore opportunities to join our organization and contribute to our mission. We are currently seeking a Quality Assurance Manager to support our expanding commercial footprint at our on-site facility in Charlottesville, Virginia.
Overview of this Position: The Quality Assurance Manager leads quality oversight for sterile manufacturing operations, ensuring full compliance with FDA regulations, EU GMP, and Annex 1 requirements. This role is responsible for batch record review and lot release, as well as driving robust deviation investigations and CAPA management to maintain product sterility assurance and regulatory compliance. The QA Manager partners closely with manufacturing, quality control, and engineering teams to support efficient production while upholding the highest standards of aseptic processing and contamination control in a dynamic, growth-oriented environment.
Non-Negotiable Requirements:
• Bachelor's degree in biology or related field
• Strong working knowledge of FDA regulations, EU GMP, and Annex 1
• Proven working experience in lot release, deviation management, and CAPA systems
• Experience supporting regulatory inspections and audits (FDA/Client)
• Excellent problem-solving, communication, and leadership skills.
Preferred Requirements:
• Experience with electronic quality management systems (eQMS).
• Strong understanding of risk management principles (e.g., ICH Q9).
• Ability to manage multiple priorities in a fast-paced environment.
Responsibilities Include:
• Ensure operations are conducted in accordance with applicable FDA regulations, EU GMP requirements, and Annex 1 guidance for both sterile and non-sterile manufacturing activities
• Review batch records and supporting documentation in accordance with approved procedures to ensure product quality and data integrity prior to disposition
• Lead and support deviation investigations, including documentation of root cause analysis and implementation of timely, compliant resolutions
• Develop, implement, and track Corrective and Preventive Actions (CAPAs) in alignment with quality system requirements to mitigate recurrence of identified issues
• Review and approve SOPs, protocols, and validation documentation related to sterilization processes, aseptic filling, cleaning, and gowning practices
• Ensure personnel qualification and training requirements for aseptic operations- including media fills and gowning qualifications-are maintained, current, and effective
• Support internal and external audits, including regulatory inspections, and maintain a state of audit readiness; serve as a subject matter expert for sterile manufacturing and Annex 1 compliance when required
• Partner with Manufacturing, Quality Control, and Regulatory Affairs to ensure alignment on quality standards, expectations, and regulatory commitments
• Monitor quality metrics and performance indicators to identify trends and support continuous improvement initiatives
• Provide guidance and training to QA personnel and cross-functional teams on quality systems, compliance expectations, and best practices; support departmental operations and staff development
The duties listed above are intended to describe the essential functions of this position. Additional responsibilities may be assigned as needed. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this job. This role may require sitting, standing, or walking for extended periods, using a computer, and working in a standard office environment. Specific physical or environmental requirements will be addressed through the reasonable accommodation process. We do not discriminate based on disability and will provide reasonable accommodation as required by law.
About Afton Scientific
Sourced by ZipRecruiter
Industry
Transportation and warehousing
Company size
1 - 10 Employees
Headquarters location
Charlottesville, VA, US
Year founded
1991