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 ...
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 ...
... managers and pharmacies to enable significant cost savings to be passed along to their customers ... Lead and coordinate Aseptic Process Simulation (media fill) programs, including design, execution ...
... managers and pharmacies to enable significant cost savings to be passed along to their customers ... Lead and coordinate Aseptic Process Simulation (media fill) programs, including design, execution ...
... managers and pharmacies to enable significant cost savings to be passed along to their customers ... Lead and coordinate Aseptic Process Simulation (media fill) programs, including design, execution ...
... managers and pharmacies to enable significant cost savings to be passed along to their customers ... Lead and coordinate Aseptic Process Simulation (media fill) programs, including design, execution ...
Mechanical/HVAC Engineer
Reston, VA · On-site
$88K - $118K/yr
The ideal candidate has a strong background in cleanroom environments, aseptic processing ... management experience Familiarity with risk-based contamination control strategies
Quick apply
Mechanical/HVAC Engineer
Reston, VA · On-site
$88K - $118K/yr
The ideal candidate has a strong background in cleanroom environments, aseptic processing ... management experience Familiarity with risk-based contamination control strategies
... manage cleaning validation programs. Plan validation efforts using a risk-based approach. · Provide oversight and direction to Aseptic Processing Simulation (APS) and Air Visualization Studies. · ...
... manage cleaning validation programs. Plan validation efforts using a risk-based approach. · Provide oversight and direction to Aseptic Processing Simulation (APS) and Air Visualization Studies. · ...
Director, Validation
Petersburg, VA · On-site
... Implement and manage cleaning validation programs. Plan validation efforts using a risk-based approach. • Provide oversight and direction to Aseptic Processing Simulation (APS) and Air ...
Director, Validation
Petersburg, VA · On-site
... Implement and manage cleaning validation programs. Plan validation efforts using a risk-based approach. • Provide oversight and direction to Aseptic Processing Simulation (APS) and Air ...
... Aseptic Process simulation protocols and reports; process validation (PPQ), and cleaning ... Leading and Managing projects for the validation of equipment, processes, and products to meet all ...
... Aseptic Process simulation protocols and reports; process validation (PPQ), and cleaning ... Leading and Managing projects for the validation of equipment, processes, and products to meet all ...
... Aseptic Techniques Attention to details Business Acumen Communication Communication with multi-levels Computer skills Critical Thinking Decision making Financial Management HIPAA Infection Control ...
... Aseptic Techniques Attention to details Business Acumen Communication Communication with multi-levels Computer skills Critical Thinking Decision making Financial Management HIPAA Infection Control ...
Manager Sterile Processing
Richmond, VA · On-site
... Aseptic Techniques Attention to details Business Acumen Communication Communication with multi-levels Computer skills Critical Thinking Decision making Financial Management HIPAA Infection Control ...
Manager Sterile Processing
Richmond, VA · On-site
... Aseptic Techniques Attention to details Business Acumen Communication Communication with multi-levels Computer skills Critical Thinking Decision making Financial Management HIPAA Infection Control ...
... Aseptic Techniques Attention to details Business Acumen Communication Communication with multi-levels Computer skills Critical Thinking Decision making Financial Management HIPAA Infection Control ...
... Aseptic Techniques Attention to details Business Acumen Communication Communication with multi-levels Computer skills Critical Thinking Decision making Financial Management HIPAA Infection Control ...
Manager Sterile Processing
Richmond, VA · On-site
... Aseptic Techniques Attention to details Business Acumen Communication Communication with multi-levels Computer skills Critical Thinking Decision making Financial Management HIPAA Infection Control ...
Manager Sterile Processing
Richmond, VA · On-site
... Aseptic Techniques Attention to details Business Acumen Communication Communication with multi-levels Computer skills Critical Thinking Decision making Financial Management HIPAA Infection Control ...
... Aseptic Techniques Attention to details Business Acumen Communication Communication with multi-levels Computer skills Critical Thinking Decision making Financial Management HIPAA Infection Control ...
... Aseptic Techniques Attention to details Business Acumen Communication Communication with multi-levels Computer skills Critical Thinking Decision making Financial Management HIPAA Infection Control ...
... Service Materiel Management), CRCST (Certified Registered Central Service Technician), or ... Demonstrates knowledge of instrumentation and sterile/aseptic technique. Ability to read and ...
... Service Materiel Management), CRCST (Certified Registered Central Service Technician), or ... Demonstrates knowledge of instrumentation and sterile/aseptic technique. Ability to read and ...
... Service Materiel Management), CRCST (Certified Registered Central Service Technician), or ... Demonstrates knowledge of instrumentation and sterile/aseptic technique. Ability to read and ...
... Service Materiel Management), CRCST (Certified Registered Central Service Technician), or ... Demonstrates knowledge of instrumentation and sterile/aseptic technique. Ability to read and ...
... for HP Hood ESL and Aseptic products. Essential Duties and Responsibilities: * Administer ... Manage schedules and receive daily deliveries of liquid ingredients, following mandated processes ...
... for HP Hood ESL and Aseptic products. Essential Duties and Responsibilities: * Administer ... Manage schedules and receive daily deliveries of liquid ingredients, following mandated processes ...
... for HP Hood ESL and Aseptic products. Essential Duties and Responsibilities: * Administer ... Manage schedules and receive daily deliveries of liquid ingredients, following mandated processes ...
... for HP Hood ESL and Aseptic products. Essential Duties and Responsibilities: * Administer ... Manage schedules and receive daily deliveries of liquid ingredients, following mandated processes ...
... for HP Hood ESL and Aseptic products. Essential Duties and Responsibilities: * Administer ... Manage schedules and receive daily deliveries of liquid ingredients, following mandated processes ...
Quick apply
... for HP Hood ESL and Aseptic products. Essential Duties and Responsibilities: * Administer ... Manage schedules and receive daily deliveries of liquid ingredients, following mandated processes ...
Notify appropriate CTL or Manager when unable to replace parts or with equipment deficiencies in ... Apply aseptic technique in daily work assignments. * Cleans and/or safely operates selected ...
Notify appropriate CTL or Manager when unable to replace parts or with equipment deficiencies in ... Apply aseptic technique in daily work assignments. * Cleans and/or safely operates selected ...
Notify appropriate CTL or Manager when unable to replace parts or with equipment deficiencies in ... Apply aseptic technique in daily work assignments. * Cleans and/or safely operates selected ...
Notify appropriate CTL or Manager when unable to replace parts or with equipment deficiencies in ... Apply aseptic technique in daily work assignments. * Cleans and/or safely operates selected ...
Director, Drug Product Manufacturing (Hopewell, NJ)
Hopewell, VA · On-site
$167K - $227K/yr
This position reports directly to the General Manager (Site Head) and is a site leadership position ... lyophilization, aseptic processing). * Minimum of 7 years in a leadership role. * Deep ...
Director, Drug Product Manufacturing (Hopewell, NJ)
Hopewell, VA · On-site
$167K - $227K/yr
This position reports directly to the General Manager (Site Head) and is a site leadership position ... lyophilization, aseptic processing). * Minimum of 7 years in a leadership role. * Deep ...
Manager Aseptic Processing information
What is the difference between Manager Aseptic Processing vs Aseptic Processing Technician?
| Aspect | Manager Aseptic Processing | Aseptic Processing Technician |
|---|---|---|
| Credentials | Bachelor's degree in life sciences or related field, GMP training, leadership experience | High school diploma or associate degree, GMP training |
| Work Environment | Supervisory role overseeing aseptic processes in pharmaceutical manufacturing | Hands-on role operating aseptic equipment in cleanroom settings |
| Responsibilities | Managing teams, ensuring compliance, process optimization | Performing aseptic procedures, equipment setup, documentation |
The Manager Aseptic Processing oversees the aseptic manufacturing process, focusing on team management and compliance, while the Aseptic Processing Technician handles the direct operation of aseptic equipment. Both roles require GMP training and work in sterile environments, but the manager has additional leadership and oversight responsibilities.
What are Manager Aseptic Processing?
A Manager of Aseptic Processing oversees the sterile production environments in pharmaceutical or biotechnology manufacturing. They are responsible for ensuring that products are processed and packaged without contamination, following strict regulatory and safety standards. Their role includes supervising staff, maintaining compliance with Good Manufacturing Practices (GMP), conducting risk assessments, and implementing process improvements. They also play a key part in training employees and managing documentation to ensure product quality and patient safety.
What are some common challenges faced by a Manager in Aseptic Processing, and how can they be addressed?
Managers in Aseptic Processing often face challenges related to ensuring strict compliance with regulatory standards, maintaining a contamination-free environment, and leading cross-functional teams in high-pressure situations. Addressing these challenges requires staying updated on evolving industry guidelines, fostering a culture of continuous training, and implementing robust monitoring systems. Effective communication and collaboration with Quality Assurance, Maintenance, and Production teams are also crucial for swiftly resolving issues and upholding product safety.
What are the key skills and qualifications needed to thrive as a Manager Aseptic Processing, and why are they important?
To thrive as a Manager Aseptic Processing, you need a strong background in microbiology, pharmaceutical manufacturing, quality assurance, and regulatory compliance, often supported by a relevant degree and experience in sterile production environments. Familiarity with Good Manufacturing Practices (GMP), cleanroom management systems, and environmental monitoring tools is essential. Leadership, attention to detail, and effective communication are crucial soft skills for managing teams and ensuring strict adherence to protocols. These skills and qualities are vital to maintain product sterility, meet regulatory standards, and ensure patient safety in pharmaceutical operations.
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What are popular job titles related to Manager Aseptic Processing jobs in Virginia? For Manager Aseptic Processing jobs in Virginia, the most frequently searched job titles are:
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Full-time
Posted 3 days ago
Job description
At Afton Scientific, every role contributes to advancing the quality, reliability, and strategic impact of our sterile pharmaceutical manufacturing services. Our team is driven by innovation, collaboration, and long-term partnerships that shape the future of healthcare. We support employees at every stage of their career by fostering an environment where development, learning, and meaningful impact are possible.
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.
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