Senior Specialist GMP Operational Quality
3 days ago
Job DescriptionGeneral Summary:The Operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external manufacturing programs at VCGT. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems documentation as needed in support of product disposition.***This role is onsite 5 days per week onsite ***Key Duties and Responsibilities:• Reviews master batch records and provides customer approval for quality tasks for externally manufactured products• Performs final review of executed batch and/or critical systems documentation and determines acceptability by using standard operating procedures• Ensures presence and acceptability of all required documentation prior to the release of the product and/or system.• Reviews and approves investigations, CAPA’s and change controls for external programs• Support the day to day management of the batch release process.• Support annual product quality reviews• Assist the facility in preparation for quality audits and participate in corporate audits and external inspections as needed.• Communicates proactively with internal and external partners and management.• Maintains files such that documents are readily available and easily retrievable.• Assists department with monthly/quarterly Quality System data review metrics and reporting• Escalate critical and major finding to Quality management and monitor key performance indicators in collaboration with Quality Systems and other GXP Operational areas.Education and Experience:• Bachelor’s degree in a scientific or allied health field or the equivalent combination of education and experience• Experience providing QA support and oversight of GMP manufacturing operation• Experience successfully leading event investigations, Root Cause Analysis and CAPA• Experience with network-based applications such as Oracle, Veeva• Knowledge of current industry trends and ability to use the latest technologiesOn-Site designated role, you will work five days per week on-site with ad hoc flexibility.
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Senior Specialist, GMP Operational Quality
12 hours ago
Boston, United States Katalyst HealthCares & Life Sciences Full timeJob Description: Developing Quality Documents. Small Molecule Manufacturing. The Senior Specialist is recognized as having a functional knowledge in the principles and application of quality assurance and regulatory compliance. The Senior Specialist ensures timely delivery of activities to support developmental programs. The Senior Specialist supports or...
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Boston, United States Vertex Full timeJob DescriptionGeneral/Position SummaryThe Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product disposition. This position reports to Manager GMP Quality - Cell & GeneThe quality role...
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Senior Specialist, GMP Operational Quality
4 weeks ago
Boston, United States Katalyst Healthcares & Life Sciences Full timeSenior Specialist Quality AssuranceDeveloping quality documents in small molecule manufacturing. The Senior Specialist is recognized as having a functional knowledge in the principles and application of quality assurance and regulatory compliance. The Senior Specialist ensures timely delivery of activities to support developmental programs. The Senior...
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Operational Quality Senior Specialist
2 weeks ago
Boston, Massachusetts, United States Planet Pharma Full time $72,000 - $93,600 per yearJob DescriptionGeneral Summary:The Operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external manufacturing programs at VCGT. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release testing and...
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GMP Inventory Procurement Specialist
3 weeks ago
Boston, United States Boston Staffing Full timeGmp Inventory Procurement SpecialistThe Gmp Procurement/Inventory Specialist will be responsible for leading and managing all site ordering and spare part procurement. This position will play a key role in establishing and maintaining strong vendor relationships enterprise wide. The Gmp Procurement/Inventory Specialist will work daily to support the Gmp...
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GMP Inventory Procurement Specialist
4 weeks ago
Boston, United States Boston Staffing Full timeGmp Inventory Procurement Specialist The Gmp Procurement/Inventory Specialist will be responsible for leading and managing all site ordering and spare part procurement. This position will play a key role in establishing and maintaining strong vendor relationships enterprise wide. The Gmp Procurement/Inventory Specialist will work daily to support the Gmp...
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GMP Inventory Procurement Specialist
4 weeks ago
Boston, United States C&W Services Full timeJob Title GMP Inventory Procurement Specialist Job Description Summary The GMP Procurement/Inventory Specialist will be responsible for leading and managing all site ordering and spare part procurement. This position will play a key role in establishing and maintaining strong vendor relationships enterprise wide. The GMP Procurement/Inventory Specialist will...
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Director, GMP Operational Quality Cell and Gene
15 hours ago
Boston, United States Vertex Full timeJob DescriptionGeneral Summary:The Director GMP Quality Operations is responsible for the quality oversight of operations of the manufacturing site for the manufacture of Cell Product, including management of direct reports and defining daily priorities to execute the team’s responsibilities. The role is responsible for Quality oversight on the...
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Executive Director, Quality Assurance, GMP
5 days ago
Boston, United States Scorpion Therapeutics Full timeXenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team. We are...
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Executive Director, Quality Assurance, GMP
14 hours ago
Boston, MA, United States Scorpion Therapeutics Full timeXenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team. We are...
