Quality Assurance Manager (Batch Record Reviews & Disposition)
SIGA Technologies, Inc. (www.siga.com) is seeking a full-time (40 hours/week) Quality Assurance Manager (Batch Record Review & Disposition) to join the Research & Development team based in Corvallis, Oregon. Reporting to the Senior Director, Quality Assurance, the Quality Assurance (QA) Manager is an independent contributor responsible for overseeing and managing quality assurance activities related to manufacturing operations, with a focus on ensuring product quality and compliance throughout the product lifecycle. This includes managing batch record review, analytical data review, product disposition, supporting regulatory compliance reports, and ensuring quality oversight of shipping and distribution activities.
As a full-time employee, the QA Manager is eligible for SIGA’s full benefits package including company paid medical, dental and vision benefits, short and long-term disability, life and AD&D insurance and paid time off. This position has the option of a hybrid office or remote work arrangement and may require domestic and international travel up to 10% of the time.
Responsibilities for this position include:
Contract Manufacturing Operations (CMO) Support and Batch Record Review:
• Serve as the primary quality contact for designated CMOs.
• Supporting day-to-day manufacturing operations related to SIGA product, including resulting change controls, documents, meeting attendance, etc.
• Reviewing and approving master and executed batch records, ensuring they are complete, accurate, and compliant with cGMPs (Good Manufacturing Practices) and company procedures.
• Ensure timely closure of batch record discrepancies and deviations, collaborating with manufacturing and other departments to resolve issues.
• Develop and implement continuous improvement initiatives for batch record review processes to enhance efficiency and compliance.
Analytical Data Review:
• Review and approve analytical data, including raw material testing, in-process testing, and finished product release testing, to ensure accuracy, completeness, and compliance with specifications.
• Supporting the investigations of Out-of-Specification (OOS) and Out-of-Trend (OOT) results, ensuring proper root cause analysis and corrective actions are implemented, and escalating such events as warranted/required by internal procedure.
• Collaborate with contracted test labs to ensure laboratory testing is conducted appropriately and meets required standards.
• Review and approve protocols, data, reports, and trends.
Product Disposition:
• Perform or oversee the final disposition (release or rejection) of products, ensuring they meet all quality standards and regulatory requirements before release to market.
• Provide guidance and support for product holds related to quality non-conformance.
• Direct product disposition decisions, including shipment, for various materials like intermediates, semi-finished products, and finished drug products.
Supporting Compliance Reports:
• Support the preparation of compliance reports, such as Annual Product Quality Reports (APQR) and regulatory submissions.
• Collaborate with cross-functional teams to gather data and information needed for compliance reporting.
• Ensure all documentation required by regulatory bodies is accurately completed and readily available for audits.
Shipping and Distribution:
• Ensure quality oversight of shipping and distribution activities, including processes related to temperature excursions during product shipment.
• Manage and resolve quality incidents/complaints related to product distribution, collaborating with suppliers and distributors on corrective and preventive actions.
Quality Management Systems:
• Manage and improve internal processes and procedures for manufacturing operations.
• Support GMP investigations/deviations, CAPAs, and Change Controls related to manufacturing and distribution.
• Contribute to management reviews of quality metrics and performance.
Quality Culture:
• Foster a culture of quality, compliance, and continuous improvement within the QA team and across the organization.
Other duties as assigned
Minimum Qualifications include:
Bachelor's Degree in a science-related field (e.g., Biology, Chemistry, Pharmacy) with 10+ years of relevant GMP experience in a regulated industry, such as pharmaceuticals, biotechnology, or device.
Demonstrated experience in batch record review, analytical data review, and product disposition.
Demonstrated experience successfully complying with regulations related to shipping and distribution of products.
Certification from a quality professional organization (e.g., ASQ CQA), preferred.
The successful candidate will possess the following knowledge and abilities:
• Experience with specific regulations related to shipping and distribution of products
• Knowledge of cGMP and GLP regulations and relevant industry guidelines (e.g., FDA, EMA, ICH, ISO, etc..).
• Excellent communication skills, both written and verbal, for effective collaboration with internal teams and external stakeholders.
• Excellent organizational and problem-solving skills.
• Experience with Quality Management Systems and quality improvement methodologies (e.g., CAPA, deviations, investigations, change controls, etc.).
• Meticulous attention to detail in reviewing processes, documentation, and data.
About SIGA:
SIGA is a leader in global health, developing medicines to prevent and treat emerging infectious diseases with high unmet medical needs.
Join our team of recognized industry thought leaders who are passionate about global health security. At SIGA, you'll find a driven and compassionate team dedicated to making a difference. We foster a supportive and inclusive culture and encourage multi-disciplinary collaboration and professional development. Discover a fulfilling career with opportunities for advancement while protecting lives around the world.
We foster a workplace where every individual is respected and appreciated for the unique value they bring to our team. We ensure a professional environment that promotes inclusion and diversity of thought. Our policies and procedures ensure equal employment opportunity without discrimination or harassment on the basis of race (including hairstyle/texture), color, religion, sex, sexual orientation, gender identity or expression, age, disability, marital status, citizenship, national origin, genetic information, veteran’s status or any other characteristics protected by law. SIGA strictly prohibits any such discrimination, harassment, or retaliation for claims submitted in good faith.
Apply Now
Apply Now
As a full-time employee, the QA Manager is eligible for SIGA’s full benefits package including company paid medical, dental and vision benefits, short and long-term disability, life and AD&D insurance and paid time off. This position has the option of a hybrid office or remote work arrangement and may require domestic and international travel up to 10% of the time.
Responsibilities for this position include:
Contract Manufacturing Operations (CMO) Support and Batch Record Review:
• Serve as the primary quality contact for designated CMOs.
• Supporting day-to-day manufacturing operations related to SIGA product, including resulting change controls, documents, meeting attendance, etc.
• Reviewing and approving master and executed batch records, ensuring they are complete, accurate, and compliant with cGMPs (Good Manufacturing Practices) and company procedures.
• Ensure timely closure of batch record discrepancies and deviations, collaborating with manufacturing and other departments to resolve issues.
• Develop and implement continuous improvement initiatives for batch record review processes to enhance efficiency and compliance.
Analytical Data Review:
• Review and approve analytical data, including raw material testing, in-process testing, and finished product release testing, to ensure accuracy, completeness, and compliance with specifications.
• Supporting the investigations of Out-of-Specification (OOS) and Out-of-Trend (OOT) results, ensuring proper root cause analysis and corrective actions are implemented, and escalating such events as warranted/required by internal procedure.
• Collaborate with contracted test labs to ensure laboratory testing is conducted appropriately and meets required standards.
• Review and approve protocols, data, reports, and trends.
Product Disposition:
• Perform or oversee the final disposition (release or rejection) of products, ensuring they meet all quality standards and regulatory requirements before release to market.
• Provide guidance and support for product holds related to quality non-conformance.
• Direct product disposition decisions, including shipment, for various materials like intermediates, semi-finished products, and finished drug products.
Supporting Compliance Reports:
• Support the preparation of compliance reports, such as Annual Product Quality Reports (APQR) and regulatory submissions.
• Collaborate with cross-functional teams to gather data and information needed for compliance reporting.
• Ensure all documentation required by regulatory bodies is accurately completed and readily available for audits.
Shipping and Distribution:
• Ensure quality oversight of shipping and distribution activities, including processes related to temperature excursions during product shipment.
• Manage and resolve quality incidents/complaints related to product distribution, collaborating with suppliers and distributors on corrective and preventive actions.
Quality Management Systems:
• Manage and improve internal processes and procedures for manufacturing operations.
• Support GMP investigations/deviations, CAPAs, and Change Controls related to manufacturing and distribution.
• Contribute to management reviews of quality metrics and performance.
Quality Culture:
• Foster a culture of quality, compliance, and continuous improvement within the QA team and across the organization.
Other duties as assigned
Minimum Qualifications include:
Bachelor's Degree in a science-related field (e.g., Biology, Chemistry, Pharmacy) with 10+ years of relevant GMP experience in a regulated industry, such as pharmaceuticals, biotechnology, or device.
Demonstrated experience in batch record review, analytical data review, and product disposition.
Demonstrated experience successfully complying with regulations related to shipping and distribution of products.
Certification from a quality professional organization (e.g., ASQ CQA), preferred.
The successful candidate will possess the following knowledge and abilities:
• Experience with specific regulations related to shipping and distribution of products
• Knowledge of cGMP and GLP regulations and relevant industry guidelines (e.g., FDA, EMA, ICH, ISO, etc..).
• Excellent communication skills, both written and verbal, for effective collaboration with internal teams and external stakeholders.
• Excellent organizational and problem-solving skills.
• Experience with Quality Management Systems and quality improvement methodologies (e.g., CAPA, deviations, investigations, change controls, etc.).
• Meticulous attention to detail in reviewing processes, documentation, and data.
About SIGA:
SIGA is a leader in global health, developing medicines to prevent and treat emerging infectious diseases with high unmet medical needs.
Join our team of recognized industry thought leaders who are passionate about global health security. At SIGA, you'll find a driven and compassionate team dedicated to making a difference. We foster a supportive and inclusive culture and encourage multi-disciplinary collaboration and professional development. Discover a fulfilling career with opportunities for advancement while protecting lives around the world.
We foster a workplace where every individual is respected and appreciated for the unique value they bring to our team. We ensure a professional environment that promotes inclusion and diversity of thought. Our policies and procedures ensure equal employment opportunity without discrimination or harassment on the basis of race (including hairstyle/texture), color, religion, sex, sexual orientation, gender identity or expression, age, disability, marital status, citizenship, national origin, genetic information, veteran’s status or any other characteristics protected by law. SIGA strictly prohibits any such discrimination, harassment, or retaliation for claims submitted in good faith.
Apply Now
Apply Now