Associate Director - Microbiology and Sterility Assurance
Title: Associate Director, Microbiology & Sterility Assurance Location: Asheville, NC The Associate Director of Microbiology & Sterility Assurance is a key quality leadership role responsible for overseeing microbiological practices and ensuring compliance with regulatory standards in a manufacturing facility. This position plays a critical role in ensuring product safety and efficacy through rigorous microbiological testing, risk assessment, and contamination control. The role provides expertise and guidance in interpreting government regulations, industry guidelines, and internal requirements to maintain compliance. Key Responsibilities: Develop and implement sterility assurance strategies, policies, and procedures for the manufacturing site. Establish and oversee microbiology programs, including environmental monitoring, microbial identification, and microbiological testing. Identify gaps, resolve discrepancies, and develop action plans to enhance compliance. Manage the microbiology laboratory, directing a team of professionals, prioritizing testing activities, and ensuring timely and accurate product release. Ensure adherence to regulatory requirements and industry standards, including FDA, EMA, PIC/S, USP, and ICH guidelines. Assess the impact of new regulations, implement necessary changes, and lead the development of process flows and procedures. Oversee sterile manufacturing operations, including cleanroom facilities, sterilization processes, and aseptic processing techniques. Provide direct leadership, including mentoring, performance management, and staffing decisions, for a large team of employees. Conduct risk assessments and root cause analyses for sterility assurance and microbiology-related issues, developing effective corrective and preventive actions. Foster strong collaboration with cross-functional teams, including manufacturing, quality control, and R&D, to ensure effective coordination of microbiology and sterility assurance activities. Participate in regulatory inspections and audits, responding to inquiries and observations from regulatory authorities. Manage departmental budgets, focusing on cost control and efficiency improvements. Stay informed of industry trends, emerging technologies, and best practices in sterility assurance and microbiology. Qualifications & Experience: Bachelor's degree in microbiology, pharmacy, biology, or a related scientific field (Master's or PhD preferred). At least 10 years of experience in microbiology, sterility assurance, aseptic processing, or related fields in pharmaceutical or biotech manufacturing. Strong knowledge of regulatory requirements and industry standards for sterile manufacturing and aseptic processing. Expertise in microbiology-related regulations, including environmental monitoring, microbial identification, and microbiological testing. Proven leadership and team management skills, with the ability to develop and motivate teams to achieve goals. Strong analytical and problem-solving abilities, including experience conducting root cause analyses and implementing corrective and preventive actions. Excellent communication and interpersonal skills, with the ability to collaborate across teams and convey complex technical information effectively. Experience with regulatory inspections and audits is a plus. This role is ideal for a microbiology and sterility assurance professional seeking an opportunity to lead critical quality functions within a regulated manufacturing environment. If this sounds of interest, please don't hesitate to apply!
Negotiable
Asheville
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Associate Director, Microbiology and Sterility Assurance
Title: Associate Director, Microbiology & Sterility Assurance Location: Asheville, NC The Associate Director of Microbiology & Sterility Assurance is a key quality leadership role responsible for overseeing microbiological practices and ensuring compliance with regulatory standards in a manufacturing facility. This position plays a critical role in ensuring product safety and efficacy through rigorous microbiological testing, risk assessment, and contamination control. The role provides expertise and guidance in interpreting government regulations, industry guidelines, and internal requirements to maintain compliance. Key Responsibilities: Develop and implement sterility assurance strategies, policies, and procedures for the manufacturing site. Establish and oversee microbiology programs, including environmental monitoring, microbial identification, and microbiological testing. Identify gaps, resolve discrepancies, and develop action plans to enhance compliance. Manage the microbiology laboratory, directing a team of professionals, prioritizing testing activities, and ensuring timely and accurate product release. Ensure adherence to regulatory requirements and industry standards, including FDA, EMA, PIC/S, USP, and ICH guidelines. Assess the impact of new regulations, implement necessary changes, and lead the development of process flows and procedures. Oversee sterile manufacturing operations, including cleanroom facilities, sterilization processes, and aseptic processing techniques. Provide direct leadership, including mentoring, performance management, and staffing decisions, for a large team of employees. Conduct risk assessments and root cause analyses for sterility assurance and microbiology-related issues, developing effective corrective and preventive actions. Foster strong collaboration with cross-functional teams, including manufacturing, quality control, and R&D, to ensure effective coordination of microbiology and sterility assurance activities. Participate in regulatory inspections and audits, responding to inquiries and observations from regulatory authorities. Manage departmental budgets, focusing on cost control and efficiency improvements. Stay informed of industry trends, emerging technologies, and best practices in sterility assurance and microbiology. Qualifications & Experience: Bachelor's degree in microbiology, pharmacy, biology, or a related scientific field (Master's or PhD preferred). At least 10 years of experience in microbiology, sterility assurance, aseptic processing, or related fields in pharmaceutical or biotech manufacturing. Strong knowledge of regulatory requirements and industry standards for sterile manufacturing and aseptic processing. Expertise in microbiology-related regulations, including environmental monitoring, microbial identification, and microbiological testing. Proven leadership and team management skills, with the ability to develop and motivate teams to achieve goals. Strong analytical and problem-solving abilities, including experience conducting root cause analyses and implementing corrective and preventive actions. Excellent communication and interpersonal skills, with the ability to collaborate across teams and convey complex technical information effectively. Experience with regulatory inspections and audits is a plus. This role is ideal for a microbiology and sterility assurance professional seeking an opportunity to lead critical quality functions within a regulated manufacturing environment. If this sounds of interest, please don't hesitate to apply!
Negotiable
Asheville
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Complaint Specialist - Dialysis Technician
Job Summary: We are seeking a dedicated and detail-oriented Complaint Specialist to join our team. The ideal candidate will have experience as a dialysis technician or nurse and will be responsible for managing and resolving customer complaints related to our medical devices. This role is critical in ensuring customer satisfaction and maintaining the highest standards of product quality and safety. Key Responsibilities: Receive, document, and investigate customer complaints related to medical devices. Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Engineering, to resolve complaints effectively. Conduct root cause analysis and implement corrective and preventive actions (CAPA) to address issues. Maintain accurate and detailed records of all complaint investigations and resolutions. Ensure compliance with regulatory requirements and company policies. Provide timely and clear communication to customers regarding the status and resolution of their complaints. Analyze complaint data to identify trends and areas for improvement. Participate in internal and external audits as required. Qualifications: Experience as a dialysis technician or nurse is required. Bachelor's degree in a related field or equivalent work experience. Strong understanding of medical device regulations and quality standards (e.g., FDA, ISO 13485). Excellent problem-solving and analytical skills. Strong communication and interpersonal skills. Ability to work independently and as part of a team. Detail-oriented with strong organizational skills. Proficiency in Microsoft Office Suite and complaint management software. Fluent German
Negotiable
Region Hannover
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Complaint Specialist - Dialysis Technician/Nurse
Job Summary: We are seeking a dedicated and detail-oriented Complaint Specialist to join our team. The ideal candidate will have experience as a dialysis technician or nurse and will be responsible for managing and resolving customer complaints related to our medical devices. This role is critical in ensuring customer satisfaction and maintaining the highest standards of product quality and safety. Key Responsibilities: Receive, document, and investigate customer complaints related to medical devices. Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Engineering, to resolve complaints effectively. Conduct root cause analysis and implement corrective and preventive actions (CAPA) to address issues. Maintain accurate and detailed records of all complaint investigations and resolutions. Ensure compliance with regulatory requirements and company policies. Provide timely and clear communication to customers regarding the status and resolution of their complaints. Analyze complaint data to identify trends and areas for improvement. Participate in internal and external audits as required. Qualifications: Experience as a dialysis technician or nurse is required. Bachelor's degree in a related field or equivalent work experience. Strong understanding of medical device regulations and quality standards (e.g., FDA, ISO 13485). Excellent problem-solving and analytical skills. Strong communication and interpersonal skills. Ability to work independently and as part of a team. Detail-oriented with strong organizational skills. Proficiency in Microsoft Office Suite and complaint management software. Fluent German
Negotiable
Region Hannover
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Complaint Specialist - Dialysis Technician/Nurse
Job Summary: We are seeking a dedicated and detail-oriented Complaint Specialist to join our team. The ideal candidate will have experience as a dialysis technician or nurse and will be responsible for managing and resolving customer complaints related to our medical devices. This role is critical in ensuring customer satisfaction and maintaining the highest standards of product quality and safety. Key Responsibilities: Receive, document, and investigate customer complaints related to medical devices. Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Engineering, to resolve complaints effectively. Conduct root cause analysis and implement corrective and preventive actions (CAPA) to address issues. Maintain accurate and detailed records of all complaint investigations and resolutions. Ensure compliance with regulatory requirements and company policies. Provide timely and clear communication to customers regarding the status and resolution of their complaints. Analyze complaint data to identify trends and areas for improvement. Participate in internal and external audits as required. Qualifications: Experience as a dialysis technician or nurse is required. Bachelor's degree in a related field or equivalent work experience. Strong understanding of medical device regulations and quality standards (e.g., FDA, ISO 13485). Excellent problem-solving and analytical skills. Strong communication and interpersonal skills. Ability to work independently and as part of a team. Detail-oriented with strong organizational skills. Proficiency in Microsoft Office Suite and complaint management software. Fluent German
Negotiable
Region Hannover
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Quality Assurance Specialist
Job Title: Quality Assurance Specialist Location: Japan Industry: Biotechnology Company Overview: Join our leading biotechnology company dedicated to advancing healthcare through innovative and high-quality products. We are seeking a dedicated Quality Assurance Specialist to ensure our products meet the highest standards of quality and compliance. Key Responsibilities: Develop, implement, and maintain quality assurance protocols and procedures in compliance with cGMP and regulatory requirements. Conduct regular audits and inspections of manufacturing processes to ensure adherence to quality standards. Review and approve production and quality control records. Manage and investigate quality-related issues, including deviations, non-conformances, and CAPAs (Corrective and Preventive Actions). Ensure proper documentation and archiving of quality assurance activities. Collaborate with cross-functional teams to support continuous improvement initiatives. Provide training and guidance to staff on quality assurance practices and regulatory requirements. Stay updated with the latest industry trends and regulatory changes to ensure compliance. Qualifications: Bachelor's degree in Science, Chemistry, Pharmacy or a related field; advanced degrees are advantageous. Minimum of 5 years of experience in quality assurance. Strong knowledge of cGMP, regulatory requirements, and quality management systems. Excellent analytical, problem-solving, and communication skills. Proficiency in Japanese and English. Ability to work effectively in a fast-paced, dynamic environment.
Negotiable
Japan
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Freelance Quality Assurance Engineer
Urgent Freelance Quality Assurance Engineering Consultant (Pharmaceutical Industry) Location: Northern Germany Duration: Immediate Start - 12-Month Contract Language: Must be German-speaking We are working exclusively with a large pharmaceutical client to find a highly skilled Quality Assurance Engineering Consultant with expertise in Deviation Management, CAPA, and documentation within the pharmaceutical industry. This is a crucial role to ensure that quality systems meet regulatory requirements and maintain high standards in a highly regulated environment. Key Responsibilities: Deviation Management: Manage, investigate, and resolve quality deviations, ensuring compliance with regulatory requirements. CAPA: Develop and monitor CAPA plans, collaborate with teams to ensure resolution, and track compliance. Documentation: Ensure proper documentation and adherence to all required quality standards and regulations. Regulatory Compliance: Ensure adherence to global standards (FDA, EMA, ICH), support audits, and track regulatory changes. Continuous Improvement: Drive process improvements, implement best practices, and mentor internal teams. Qualifications and Skills: Proven experience in Quality Assurance (Deviation Management, CAPA, documentation). Strong knowledge of GSP and regulatory compliance standards. Excellent problem-solving, communication, and analytical skills. How to Apply: If you're a great fit, 📩 let's connect! DM me or share a time to chat.
Negotiable
Germany
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Freelance CQV Engineering
Urgent Freelance CQV Engineering Consultant (Pharmaceutical Industry) Location: Northern Germany Duration: Immediate Start - 12-Month Contract Language: Must be German-speaking Company Overview: We are working exclusively with a leading pharmaceutical client to find a highly skilled CQV Engineering for a high-impact project in Northern Germany. Key Responsibilities: Lead CQV for automation systems (DCS, PLC, SCADA). Develop process strategies for continuous improvement. Create and review validation documentation (protocols, reports, SOPs). Ensure GMP, FDA, and industry compliance. Troubleshoot issues during commissioning and qualification. Provide lifecycle support for automation systems. Conduct risk assessments and mitigation strategies. Provide lifecycle support for automation system How to Apply: If you're a great fit, 📩 let's connect! DM me or share a time to chat.
Negotiable
Germany
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Analytical Technical Manager
Job Summary Develop, apply, and maintain quality standards for sample testing processes and comply with regulations. Schedule meetings with management to update them on projects and equipment. Essential Responsibilities Implement management activities within SOPs for the lab and R&D/Validation tests. Work in cross-functional teams to achieve departmental goals. Ensure lab personnel follow good documentation and lab practices. Provide technical expertise for customer inquiries. Maintain impartiality and communicate potential risks to management and Quality Assurance. Assist in writing and revising SOPs and associated documents. Contribute to training modules and ensure effective training. Manage the Department PT program and stay updated on regulatory procedures. Oversee R&D, Validation, and optimization of lab testing services. Ensure adherence to method validation and transfer processes. Manage the dashboard for testing services and interact with management for resources. Participate in audits and recommend responses to complaints. Operate and maintain lab equipment, including preventive maintenance. Maintain technical competence by attending conferences and seminars. Ensure safe work practices in the lab with the Safety Officer/Committee. Minimum Qualifications Baccalaureate Degree in Biological or Chemical Science required; Master's preferred. Ten years of experience in the cosmetic, pharmaceutical, or related field, and four years in regulatory, quality control, or quality assurance preferred. Proficiency in 21 CFR, USP/NF, EP, JP, AOAC, ICH, GxP, cGMP, cGLP, and/or ISO standards. Excellent communication skills in English. Strong problem-solving abilities. Proficiency in using Windows programs and various lab software. Ability to lift and move heavy lab items. Ability to work efficiently under pressure in a fast-paced environment.
Negotiable
New York
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Senior Quality Assurance Specialist
Job Title: Senior Quality Assurance Specialist Location: Japan Industry: Pharmaceutical Company Overview: Join a leading pharmaceutical company dedicated to advancing healthcare through innovative and high-quality products. We are seeking a dedicated Quality Assurance Specialist with a Pharmacist license to ensure our products meet the highest standards of quality and compliance. Key Responsibilities: Develop, implement, and maintain quality assurance protocols and procedures in compliance with cGMP and regulatory requirements. Conduct regular audits and inspections of manufacturing processes to ensure adherence to quality standards. Review and approve production and quality control records. Manage and investigate quality-related issues, including deviations, non-conformances, and CAPAs (Corrective and Preventive Actions). Ensure proper documentation and archiving of quality assurance activities. Collaborate with cross-functional teams to support continuous improvement initiatives. Provide training and guidance to staff on quality assurance practices and regulatory requirements. Stay updated with the latest industry trends and regulatory changes to ensure compliance. Qualifications: Licensed Pharmacist in Japan. Bachelor's degree in Pharmacy or a related field; advanced degrees are advantageous. Minimum of 5 years of experience in quality assurance within the pharmaceutical industry. Strong knowledge of cGMP, regulatory requirements, and quality management systems. Excellent analytical, problem-solving, and communication skills. Proficiency in Japanese and English. Ability to work effectively in a fast-paced, dynamic environment. 職種: 品質保証スペシャリスト 勤務地: 日本 業界: 製薬 会社概要: 革新的で高品質な製品を通じて医療を進展させることに専念している当社の製薬会社に参加しませんか。薬剤師免許を持つ品質保証スペシャリストを募集しています。当社の製品が最高の品質基準と規制に準拠していることを保証する役割です。 主な業務内容: cGMPおよび規制要件に準拠した品質保証プロトコルと手順の開発、実施、維持。 製造プロセスの定期的な監査と検査を実施し、品質基準の遵守を確認。 生産および品質管理記録のレビューと承認。 品質関連の問題（逸脱、不適合、是正および予防措置（CAPA））の管理と調査。 品質保証活動の適切な文書化とアーカイブ。 継続的改善イニシアチブをサポートするために、他部門と協力。 品質保証の実践と規制要件に関するスタッフへのトレーニングと指導。 業界の最新動向と規制の変更を把握し、コンプライアンスを確保。 資格: 日本の薬剤師免許を保有。 薬学または関連分野の学士号（上級学位は有利）。 製薬業界での品質保証の経験が最低5年。 cGMP、規制要件、および品質管理システムに関する強い知識。 優れた分析力、問題解決能力、およびコミュニケーションスキル。 日本語と英語に堪能。 迅速で動的な環境で効果的に働く能力。
Negotiable
日本
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