Quality Assurance Manager

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      "role": "<meta><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><b><strong style=\"white-space:pre-wrap;\">Overview of this Position: </strong></b><span style=\"white-space:pre-wrap;\">The </span><b><strong style=\"white-space:pre-wrap;\">Quality Assurance Manager</strong></b><span style=\"white-space:pre-wrap;\"> 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.</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">&nbsp;</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><b><strong style=\"white-space:pre-wrap;\">Non-Negotiable Requirements:</strong></b></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">• Bachelor’s degree in biology or related field</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">• Strong working knowledge of FDA regulations, EU GMP, and Annex 1</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">•Proven working experience in lot release, deviation management, and CAPA systems</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">•Experience supporting regulatory inspections and audits (FDA/Client)</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">•Excellent problem-solving, communication, and leadership skills.</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">&nbsp;</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">&nbsp;</span><b><strong style=\"white-space:pre-wrap;\">Preferred Requirements:</strong></b></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">•Experience with electronic quality management systems (eQMS).</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">•Strong understanding of risk management principles (e.g., ICH Q9).</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">•Ability to manage multiple priorities in a fast-paced environment.</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">&nbsp;</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">&nbsp;</span><b><strong style=\"white-space:pre-wrap;\">Responsibilities Include:</strong></b></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">• Ensure operations are conducted in accordance with applicable </span><b><strong style=\"white-space:pre-wrap;\">FDA regulations, EU GMP requirements, and Annex 1 guidance</strong></b><span style=\"white-space:pre-wrap;\"> for both sterile and non‑sterile manufacturing activities</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">•Review batch records and supporting documentation </span><b><strong style=\"white-space:pre-wrap;\">in accordance with approved procedures</strong></b><span style=\"white-space:pre-wrap;\"> to ensure product quality and data integrity prior to disposition</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">•Lead and support </span><b><strong style=\"white-space:pre-wrap;\">deviation investigations</strong></b><span style=\"white-space:pre-wrap;\">, including documentation of root cause analysis and implementation of timely, compliant resolutions</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">•Develop, implement, and track </span><b><strong style=\"white-space:pre-wrap;\">Corrective and Preventive Actions (CAPAs)</strong></b><span style=\"white-space:pre-wrap;\"> in alignment with quality system requirements to mitigate recurrence of identified issues</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">•Review and approve </span><b><strong style=\"white-space:pre-wrap;\">SOPs, protocols, and validation documentation</strong></b><span style=\"white-space:pre-wrap;\"> related to sterilization processes, aseptic filling, cleaning, and gowning practices</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">•Ensure </span><b><strong style=\"white-space:pre-wrap;\">personnel qualification and training requirements</strong></b><span style=\"white-space:pre-wrap;\"> for aseptic operations— including media fills and gowning qualifications—are maintained, current, and effective</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">•Support internal and external audits, including </span><b><strong style=\"white-space:pre-wrap;\">regulatory inspections</strong></b><span style=\"white-space:pre-wrap;\">, and maintain a state of audit readiness; serve as a </span><b><strong style=\"white-space:pre-wrap;\">subject matter expert</strong></b><span style=\"white-space:pre-wrap;\"> for sterile manufacturing and Annex 1 compliance when required</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">•Partner with Manufacturing, Quality Control, and Regulatory Affairs to ensure </span><b><strong style=\"white-space:pre-wrap;\">alignment on quality standards, expectations, and regulatory commitments</strong></b></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">•Monitor quality metrics and performance indicators to identify trends and support </span><b><strong style=\"white-space:pre-wrap;\">continuous improvement initiatives</strong></b></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">•Provide guidance and training to QA personnel and cross‑functional teams on </span><b><strong style=\"white-space:pre-wrap;\">quality systems, compliance expectations, and best practices</strong></b><span style=\"white-space:pre-wrap;\">; support departmental operations and staff development</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">&nbsp;</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">&nbsp;</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><i><em style=\"font-size:11pt;white-space:pre-wrap;\">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.</em></i></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">&nbsp;</span></p>",
      "company": "<meta><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">At </span><b><strong style=\"white-space:pre-wrap;\">Afton Scientific</strong></b><span style=\"white-space:pre-wrap;\">, 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.</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><br></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">We invite you to explore opportunities to join our organization and contribute to our mission. We are currently seeking </span><b><strong style=\"white-space:pre-wrap;\">a Quality Assurance Manager </strong></b><span style=\"white-space:pre-wrap;\">to support our expanding commercial footprint at our </span><b><strong style=\"white-space:pre-wrap;\">on‑site facility in Charlottesville, Virginia</strong></b><span style=\"white-space:pre-wrap;\">.</span></p>"
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