- Insmed Incorporated (San Diego, CA)
- …with colleagues in other departments to increase the overall effectiveness of the Quality departmentAssist in other quality assurance related activities as ... similar function.Full understanding of GMP and Gene Therapy manufacturing.Familiarity with Quality Assurance aspects in manufacturing processes of new… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …walk-through audits of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by Manager , Quality ... and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch...pharmaceutical or biotechnology company with one (1) year direct Quality Assurance experience Knowledge, Skills, and Abilities:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and focus on the delivery and execution of non-project initiatives within R&D Quality and Global RD/PV QA by collaborating with business process owners ... on applicable Global QA processes and quality standards for continuous improvement and operations excellence. This may include the review of business partner… more
- Merck & Co. (Durham, NC)
- …culture growth, harvest, lyophilization, product inspection, and quality control laboratories.The Quality Assurance Manager will direct Shop Floor ... supporting Second Shift (Evening Shift). Responsibilities Reporting to the Quality Assurance Organization, will independently manage Shop...Assurance team on second shift.Lead a Shop Floor QA team to provide end-to-end QA support… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Will be a QA presence on the manufacturing floor. Relationships Quality Assurance . Essential Functions Reviews all manufacturing and support records to ... and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI… more
- Merck & Co. (Rahway, NJ)
- …Primary responsibilities include but are not limited to the following: Perform quality assurance activities related to API (including new modalities such ... communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance , regulatory, etc. at all levels. Establish, educate,… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist, Quality Assurance Our Company will construct a new manufacturing facility to significantly expand its ... product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.The Senior Quality Assurance … more
- Merck & Co. (Durham, NC)
- …specifically in pharmaceutical operations, technical operations, validation and/or process Quality Assurance .Required Experience and Skills:Strong Batch Record ... Job DescriptionSenior Specialist, Quality Systems and ComplianceOur company is expanding its...meet performance objectives.Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact… more
- Novo Nordisk Inc. (Durham, NC)
- …is Monday - Thursday working 10hr day shift schedule. Relationships Reports to Manager , QA . Essential Functions Ensures site compliance with Regulations, ISO ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...documentation (in conjunction with LoB). Performs archiving duties and QA presence & process confirmation on shop floor. This… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma.Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Laboratory Compliance Manager role is an exempt level position with responsibilities...experience working in an aseptic manufacturing facility, preferably in quality assurance , quality control, manufacturing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in support of site improvement projects and strategies.Be a Subject Matter Expert on quality assurance topics within the group in support of QC lab ... candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Specialist, Quality Assurance 1st Shift - Our Company constructed a new manufacturing facility to significantly expand its ... inspection, and quality control laboratories. - The Quality Assurance Specialist will support this expansion....proceed in compliance with cGMP, regulations, and our Company's Quality Management System. Provide QA shop floor… more
- Tris Pharma (Monmouth Junction, NJ)
- … Manager , Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance ( QA ) Investigations and Product Quality Complaints ... knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug-device combination… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality ... Assurance to obtain temperature excursion disposition to update impacted inventory in IRT and other related systems.Coordinates authorized destruction of investigational products with approved vendors and obtains required documentation.Vendor Management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …technical discipline is requiredA minimum of six (6) years of experience in Quality Assurance / Quality Systems or ComplianceExperience conducting internal ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based in Raritan,… more
- Aequor (Chattanooga, TN)
- …to: Sr Manager , Quality Dotted Line to: N/A Department: Quality Assurance Location: Chattanooga, TN Job Summary This contract position is responsible ... department related duties as assigned (eg - lab clean up) Interfaces Quality Assurance Quality Control (Analytical and Microbiology) CHC Research and… more
- Merck & Co. (Durham, NC)
- …and analytical sampling and assays as well as interacting with Production, Quality Assurance , Validation and Facilities, and external resources, as necessary ... the globe. The main function of the Associate Specialist, Quality Control is to assist in the assurance...the shop floorConsults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …regulations and standards, implementing best practices for workplace safety and employee training. Quality Assurance : Maintain high standards of quality in ... production, leadership skills, and a commitment to excellence in quality and safety. The Plant Manager will...excellence in quality and safety. The Plant Manager will be responsible for ensuring efficient production processes,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Change Management process. Through careful coordination with stakeholders and consistent quality assurance , minimize the risk of changes, strive for ... centered around rare diseases and immune disorders. Summary The ITSM Process Manager for Change Management is responsible and accountable for managing and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …testing strategies and processes to ensure all systems and solutions meet the required quality standards, collaborate with quality assurance teams to ensure ... to ensure that deliverables are met according to agreed timelines and quality standards. Lead a team of professionals specializing in intelligent automation,… more
