GMP Quality Control Specialist, Contract Manufacturing
3 weeks ago
Scholar Rock is a leading biopharmaceutical company dedicated to discovering, developing and delivering life-changing therapies for people with serious diseases. We are seeking a highly skilled Senior Specialist to join our Quality Assurance team.
The successful candidate will be responsible for supporting the Quality Assurance department in planning, executing and managing outsourced contract manufacturing organizations (CMOs). This includes reviewing and approving Master Batch Records, performing lot disposition and providing QA support to contract manufacturing operations.
The ideal candidate will have a strong understanding of Quality Systems and GMP regulations, as well as excellent organizational skills and the ability to work independently and handle multiple priorities. They will also be able to maintain confidentiality of proprietary information and demonstrate proficiency and knowledge of cGMP (FDA and EU) and ICH requirements.
We offer a competitive salary of $140,000 - $170,000 per annum, based on experience. Additionally, we provide a comprehensive benefits package, including health insurance, retirement plan and paid time off.
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GMP Quality Oversight Specialist
3 weeks ago
Cambridge, Massachusetts, United States Jobot Full timeJoin Jobot, a dynamic biotechnology company dedicated to developing cutting-edge treatments for chronic dermatological diseases. As a Senior Director, Quality Assurance, you will play a pivotal role in ensuring the highest quality standards across our clinical development programs and manufacturing processes.About the RoleFoster a culture of quality...
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GMP Quality Oversight Leader
3 weeks ago
Cambridge, Massachusetts, United States Jobot Full timeAbout the Role:As a Senior Director of Quality Assurance (GMP), you will be responsible for providing quality oversight of our clinical development programs and manufacturing. This role requires a strong background in biologics and operational QA experience with monoclonal antibodies.Key Responsibilities:- Provide quality support and guidance for our CMC...
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GMP Quality Director
3 weeks ago
Cambridge, Massachusetts, United States Jobot Full timeJob ResponsibilitiesWe are looking for a highly skilled Senior Quality Assurance Lead to lead our quality assurance efforts. In this critical role, you will be responsible for developing and implementing quality policies and procedures that align with regulatory requirements and industry standards. Your expertise will ensure that our quality systems meet the...
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Quality Assurance Professional
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Cambridge, Massachusetts, United States Voyager Therapeutics Full timeJoin Our TeamVoyager Therapeutics is a rapidly growing biotech company looking for a Quality Assurance Specialist to join our team. This is an exciting opportunity to be part of a dynamic organization that is making a difference in the field of gene therapy.The successful candidate will have a strong background in quality assurance and compliance, with a...
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Cambridge, Massachusetts, United States Jobot Full timeJob OverviewThis Senior Director of Quality Assurance (GMP) role is available at a publicly traded biotechnology company developing biologics to treat chronic dermatological diseases.Compensation:$240,000 - $270,000 per yearResponsibilitiesProvide quality support and guidance for CMC programsPlan, conduct or facilitate supplier qualification audits and site...
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Microbiology Quality Assurance Specialist
2 weeks ago
Cambridge, Massachusetts, United States Synectics Inc Full timeJoin a leading pharmaceutical company as a Microbiology Quality Assurance Specialist and contribute to the development of life-saving vaccines!About Synectics Inc.Synectics Inc. is a renowned manufacturer of vaccines, dedicated to improving public health worldwide.Salary: $65,000 - $80,000 per yearAs a Microbiology Quality Assurance Specialist at Synectics...
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Quality Assurance Director Lead
3 weeks ago
Cambridge, Massachusetts, United States Jobot Full timeJobot is a publicly traded biotechnology company developing innovative solutions to treat chronic dermatological diseases. We are seeking an experienced Senior Director, Quality Assurance to provide quality oversight of our clinical development programs and manufacturing.About the RoleProvide quality support and guidance for our CMC programs, ensuring...
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Director of Quality Oversight
3 weeks ago
Cambridge, Massachusetts, United States Jobot Full timeWe are a publicly traded biotechnology company developing innovative solutions to treat chronic dermatological diseases. Our team is seeking an experienced Senior Director of Quality Assurance (GMP) to provide quality oversight of our clinical development programs and manufacturing.Responsibilities:Provide quality support and guidance for our CMC...
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Director of Biologics Quality Assurance
3 weeks ago
Cambridge, Massachusetts, United States Jobot Full timeJob Summary:We are seeking an experienced Senior Director of Quality Assurance (GMP) to provide quality oversight of our clinical development programs and manufacturing. As a key member of our team, you will be responsible for ensuring the highest standards of quality and compliance in our operations.About Us:We are a publicly traded biotechnology company...
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Senior Specialist, Regulatory Compliance
3 weeks ago
Cambridge, Massachusetts, United States Scholar Rock Full timeScholar Rock is a biopharmaceutical company that discovers, develops and delivers life-changing therapies for people with serious diseases. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily, the clinical-stage company is focused on advancing innovative treatments where protein growth factors play a transformational...
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Lead Biologics Quality Assurance Director
3 weeks ago
Cambridge, Massachusetts, United States Jobot Full timeJob OverviewWe are a publicly traded biotechnology company developing innovative solutions for chronic dermatological diseases.Salary and Benefits$240,000 - $270,000 per year. Competitive salary, annual bonus, equity, ESPP, 401k program, medical/vision/dental benefits, and hybrid schedule.Job DescriptionWe seek a Senior Director of Quality Assurance (GMP) to...
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Manufacturing Quality Assurance Specialist
4 weeks ago
Cambridge, Massachusetts, United States Insight Global Full timeJob OverviewInsight Global is a leading provider of innovative staffing solutions, and we are currently seeking a highly skilled Manufacturing Quality Assurance Specialist to join our team.About the RoleThis is an exciting opportunity for a seasoned professional with expertise in Corrective and Preventative Actions (CAPA) to analyze and advise...
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Manufacturing Process Optimization Specialist
3 weeks ago
Cambridge, Massachusetts, United States Right Hire Consulting LLC Full timeJob SummaryWe are seeking a highly skilled Manufacturing Process Optimization Specialist to join our team at Right Hire Consulting LLC. As a key member of our medical device manufacturing group, you will play a crucial role in bridging R&D, pilot, and commercial manufacturing processes.ResponsibilitiesProcess Development and Validation: Develop efficient,...
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Director of Quality Assurance Biotechnology
3 weeks ago
Cambridge, Massachusetts, United States Jobot Full timeJob SummaryWe are a publicly traded biotechnology company developing innovative treatments for chronic dermatological diseases. Our team is seeking a seasoned Senior Director of Quality Assurance (GMP) to provide expert guidance on quality oversight for our clinical development programs and manufacturing processes.The ideal candidate will have extensive...
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Director of Quality Excellence
3 weeks ago
Cambridge, Massachusetts, United States Jobot Full timeWe are a publicly traded biotechnology company developing innovative biologics to address chronic dermatological diseases.The estimated salary for this position is approximately $175,000 per year, considering the industry standard and location. The role requires an expert in biologics, specifically operational QA experience with monoclonal antibodies, and a...
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Manufacturing Specialist
1 day ago
Cambridge, Massachusetts, United States Talent Groups Full timeJob OverviewTalent Groups is seeking a highly experienced Manufacturing Specialist to join our team.Key ResponsibilitiesDevelop and implement effective quality systems documentation, including deviations, change controls, batch records, and technical reports.Utilize strong knowledge of biologics drug substance production, including cell banking, plasmid...
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Manufacturing Assembly Associate
2 weeks ago
Cambridge, Massachusetts, United States Park Manufacturing Corp Inc Full timeAbout the PositionWe are seeking a motivated Manufacturing Assembly Associate to join our team at Park Manufacturing Corp Inc. The successful candidate will be responsible for performing routine assembly and sub-assembly operations in a fast-paced production environment.Key ResponsibilitiesPrepare workstations by reviewing assembly instructions, blueprint...
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Senior Manager Quality Assurance Operations
2 weeks ago
Cambridge, Massachusetts, United States Marengo Therapeutics, Inc. Full timeAbout Marengo Therapeutics, Inc.Marengo Therapeutics is a pioneering biopharmaceutical company dedicated to developing innovative therapeutics that activate the right immune response to promote lifelong protection against cancer. Our team is passionate about making a meaningful difference in the lives of patients and their loved ones.Job OverviewWe are...
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Biologics Quality Assurance Lead
3 weeks ago
Cambridge, Massachusetts, United States Third Rock Ventures Full timeRole Overview:We are seeking a highly experienced Senior Manager/Associate Director, Quality Control to lead our QC activities for antibody and fusion protein products across our pipeline.About the Job:In this role, you will develop strategies and execute QC activities for all pipeline programs. This includes in-process/release/stability testing,...
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Senior Quality Document Control Specialist
2 days ago
Cambridge, Massachusetts, United States Apex Systems Full timeAbout the Role:We are seeking a skilled Quality Document Control Specialist to join our team at Apex Systems. As a key member of our team, you will be responsible for managing and ensuring accuracy of GxP documentation, supporting training tasks, and aiding in regulatory inspections.Key Responsibilities:Manage and archive GxP documents using Veeva, ensuring...