- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for change request; manage interactions with Vendor, finalize execute amendment.- Audit Ready/ Inspection Prep: As per the audit requirement and processes, storage of ... critical procurement documents are required to be Inspection ready at all times; these documents must be clearly filed and retrievable. Perform quality audit on… more
- Merck & Co. (Durham, NC)
- …drug product, including biotech culture growth, harvest, lyophilization, product inspection , utilities, and warehouse.Manufacturing Division is a team of dedicated, ... and goalsEducation:Bachelor's Degree or higher in Engineering, Science or related field -Required:Minimum of five years' in a production and/or calibration and/or… more
- Merck & Co. (Rahway, NJ)
- …and external resources to ensure GRACS has quality driven, efficient, inspection ready business processes, and well-trained staff, equipped to perform critical ... be efficient while maintaining acceptable "compliance" and quality to ensure inspection readiness for core global GRACS business processes.Establishes and directs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …LIMs to align physical quantities of samples in freezers/refrigerators.Periodic inspection and consolidation of retains.Document and perform sample management ... or higher, a degree in Biology, Biochemistry, Microbiology, Chemistry or related field .A minimum of two (2) years related experience in medical device,… more
- Aequor (Bothell, WA)
- …hands-on operations in the areas of shipping of GMP material, receiving, inspection , storage, transferring and issuing inventory of materials, drug substance in ... intermediates and QC samples with IATA/DOT 19 CFR Certification. Receipt, inspection and quarantining of GMP raw materials and manufacturing aides. Material… more
- Novo Nordisk Inc. (Durham, NC)
- …extremely cold work environments. Occasionally positions oneself within confined spaces for inspection , repair & maintenance of equipment. Ability to work in loud ... drivers license. Qualifications Bachelor's degree in Engineering or related field of study from an accredited university required May...May consider a Associate's degree in Engineering or related field of study from an accredited university with a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Internship is a program that provides training for the intern in the field of pharmaceutical Quality Assurance focused on the activities related to the overseeing ... pharmaceutical investigations to determine root cause and corrective actions.Support inspection readiness activities, including revision, drafts, collaboration for local… more
- Merck & Co. (Rahway, NJ)
- …CenterMaintain facility and equipment systems in a state of permanent inspection readinessRecruit and develop staff, through objective setting, rewards and ... Requirement:- Ph.D. degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 7 years experience or BS or MS… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …for investigation reports that will stand alone during regulatory inspection through close collaboration with Operations and Quality teamsLead cross-functional ... Duties as assignedQualificationsEducation and Certifications:B.S./MS degree in related engineering/scientific field .Work Experience:Minimum 3 years of experience conducting deviation investigations… more
- Merck & Co. (Durham, NC)
- …drug products, including biotech culture growth, harvest, lyophilization, product inspection , utilities, and warehouse.As the team finishes the design and ... a manufacturing, technical, support, or Military role. ORBachelor's degree in a technical field AND at least four (4) years in a manufacturing, technical, support,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operating under the outsourced and in-house operating models.Is accountable for inspection readiness of external data documentation filed/archived in Trial Master ... accommodation. Education:Bachelor's Degree or higher in life sciences or related field required Work Experience:5 or more years external data management background… more
- Merck & Co. (Millsboro, DE)
- …liaison with regulatory agencies during inspections.- Ensures that all regulatory inspection observations are addressed in a complete and effective manner.Ensures ... not apply to, and daily in-person attendance is required for, field -based positions; facility-based, manufacturing-based, or research-based positions where the work… more
- Novo Nordisk Inc. (Raleigh, NC)
- …work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments ... role. Qualifications Associate's degree in Electronics, Computers, Engineering or a relevant field of study from an accredited university required Minimum of one (1)… more
- Merck & Co. (Durham, NC)
- …filling area including Thaw/Pool/Fill, Lyophilization, and Capping & Inspection .Responsibilities Provides support for all production activities, resolving critical ... not apply to, and daily in-person attendance is required for, field -based positions; facility-based, manufacturing-based, or research-based positions where the work… more
- Merck & Co. (Durham, NC)
- …hands-on media preparation, cell culture, bioreactor usage and/or purification, product inspection as well as other production-related activities. -- This is an ... not apply to, and daily in-person attendance is required for, field -based positions; facility-based, manufacturing-based, or research-based positions where the work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …first mindset, a Right First-Time culture of quality, permanent inspection readiness compliance mindset and passionately drives continuous improvementProvides ... and Engineering, MS&T, and Finance.RequirementsB.Sc./M.Sc. in Biological/Biochemical Science/Bioengineering related field or equivalent job experienceMinimally 8+ years of experience… more
- Insmed Incorporated (San Diego, CA)
- …interpretation of results and reporting that stands up to regulatory inspection .Demonstrate expert knowledge of scale-up principles with respect to viral vector ... or M.Sc. in life sciences, chemical engineering, biochemistry, or related field .5-7+ years of experience working in a biopharmaceutical laboratory focusing on… more
- Novo Nordisk Inc. (Durham, NC)
- …extremely cold work environments. Occasionally positions oneself within confined spaces for inspection , repair & maintenance of equipment. Ability to work in loud ... a valid drivers license. Qualifications Associate's degree in relevant field or equivalent military/industry training, which includes a thorough understanding… more
- Novo Nordisk Inc. (Durham, NC)
- …work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments ... vehicle based on the role. Qualifications Bachelor's Degree in a related field , or an equivalent combination of education & relevant industry experience required… more
- Novo Nordisk Inc. (Durham, NC)
- …work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments ... vehicle based on the role. Qualifications Bachelor's degree in engineering/related field or an equivalent combination of experience & education required Minimum… more
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