- 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 ... experience in a pharmaceutical or biotechnology company with one (1) year direct Quality Assurance experience Knowledge, Skills, and Abilities: Ability to work… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SUMMARYProvide support to the Global and Regional Quality Leads, External Partner Quality Leads, and Business Partner ... on assigned programs and in close collaboration with R&D Quality team members to ensure that the organization is...a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality Leads… more
- Merck & Co. (Durham, NC)
- …culture growth, harvest, lyophilization, product inspection, and quality control laboratories.The Quality Assurance Manager will direct Shop Floor ... QA oversight supporting Second Shift (Evening Shift). Responsibilities Reporting to the Quality Assurance Organization, will independently manage Shop Floor … 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal ... records. Will be a QA presence on the manufacturing floor. Relationships Quality Assurance . Essential Functions Reviews all manufacturing and support records… 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)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... make what matters. The Position Ensures Batch Production Records (BPRs) & relevant quality processes are compliant with regulations. Performs quality review &… more
- Tris Pharma (Monmouth Junction, NJ)
- …Manager , Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team ... knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug-device combination… 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
- 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....objectives. Consults on an as-needed basis with next level manager on more complex decisions. Executes critical site review… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , quality control, manufacturing compliance, clinical ... 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… 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
- 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
- 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
- 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... (EDMS) while collaborating with the Engineering team to provide necessary documentation, quality system interaction, and performing a variety of highly diverse and… more
