- Repligen (Waltham, MA)
- …critical issues through appropriate channels, ensuring long-term risk mitigation and product quality assurance.Qualifications Bachelor's degree in engineering, ... OverviewWe are seeking a Supplier Quality Engineer to join our growing Supplier Quality team. You will a key role in ensuring the quality , compliance, and… more
- Aequor (Houston, TX)
- …Critical process deviations with the aim at identification of root cause, determining Product Quality Impact (PQI) and implementation of corrective actions to ... complex scientific events into a brief and cohesive report as a finished product . Accurately capture immediate actions and containment of the event, address comments… more
- Merck & Co. (Rahway, NJ)
- …collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality .Provide Voice of Manufacturing input to ... Job DescriptionJob Summary: -The Director, Combination Product Commercialization is a key leadership role within the Device Development and Technology Organization.… more
- Eisai, Inc (Raleigh, NC)
- …batches. \tSupporting investigations and evaluating the impact of deviations or events on product quality . \tActing as a Subject Matter Expert (SME) during ... hear from you. The QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh… more
- Twist BioScience (South San Francisco, CA)
- …reports by collecting, analyzing, and summarizing information and trendsWrite/review product quality documentationFollow regulatory and ISO 13485 ... and release products based on established QC metricsMonitor QC dataInvestigate product /process/ quality issuesReview of CAPAs, process deviations, root cause… more
- Insmed Incorporated (San Diego, CA)
- …members and leadership.Knowledgeable of analytical techniques used to determine product quality and characterization of biologics.Travel RequirementsThis ... collaboration with both internal and external drug substance analytical, quality control, quality assurance, and manufacturing teams.Exercise judgment… more
- Merck & Co. (Rahway, NJ)
- …for upstream and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and ... including but not limited to Investigational New Drugs, Investigational Medicinal Product Dossier s, and Clinical Trial Application s.Ability to work closely… more
- Repligen (Rancho Dominguez, CA)
- …member in whatever capacity and job function is required to deliver a quality product to our customer in a timely fashion.ResponsibilitiesPerform manual assembly ... This assembly position performs a wide variety of fiber assembly, filtration product assembly or sub-assemblies. Determines and/or follows methods and sequence of… more
- Repligen (Clifton Park, NY)
- …Operations leadership team. Communicate effectively both internally and externally.Focus on delivering quality product to our customers based on our commitments. ... will play a key role in delivering the site expansion programs, implementing quality management systems and maintaining ISO certification. The individual will play a… more
- Merck & Co. (Rahway, NJ)
- …and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and ... a vision to develop a team, demonstrated leadership skills, sterile product technical & domain expertise, effective communication skills, understanding of regulatory… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPrincipal Scientist - Mixed Modalities, Sterile Product DevelopmentThe Mixed Modalities team within Sterile Product Development is responsible for ... development candidates, including screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for… more
- Tris Pharma (Monmouth Junction, NJ)
- …incumbent prepares, coordinates and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control ... (QC)/Regulatory Affairs, including reviews/approvals of Change Control Reports (CCRs), methods, specifications, protocols and reports. She/he acts as MV lead for assigned projects regularly reporting status/issues to management, conducts laboratory… more
- Merck & Co. (Rahway, NJ)
- …or pharmaceutical industry.In-depth knowledge of medical device and combination product regulations, manufacturing processes, and quality control.Proficiency in ... responsible for leading a team focused on developing and implementing product control strategies, statistical analysis, and advanced statistical methods for medical… more
- Repligen (Waltham, MA)
- OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology ... industry. This leader will be responsible for managing the site quality assurance team which includes all day-to-day activities for product manufacture, test and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....a difference? The Position Position is responsible for developing Quality and USO strategic objectives and strong business understanding… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....you ready to make a difference? The Position Developing quality and strategic objectives and strong business understanding of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....you ready to make a difference? The Position Developing quality and strategic objectives and strong business understanding of… more
- Merck & Co. (Durham, NC)
- …processing of both drug substance and drug product , including product inspection, warehouse, utilities, and quality control laboratories.The Specialist, ... Responsibilities:This role reports to an Operations Associate Director and supports the product transfer for a new facility in Durham, NC within Drug Substance,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these ... metrics will range from employee engagement, safe behavior, quality performance (right first time), schedule adherence, and productivity improvements.Support… more
- Merck & Co. (Rahway, NJ)
- …process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for proactive ... of and hands-on work in applying regulatory guidance and quality standards related to product release and...regulatory guidance and quality standards related to product release and safety.Current Employees apply HERE Current Contingent… more
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