- Bristol Myers Squibb (Summit, NJ)
- …our Cell Therapy team. The Associate Director, Drug Product External Manufacturing QA provides Quality oversight to Contract Manufacturing Organizations ... + Responsible for quality approval on CMO manufacturing batch record, investigations, CAPA, change control ...EMPQ, and APS. + Experience with QA oversight of drug product manufacturing , cellular therapeutics/gene-based products, and/or… more
- Lilly (Indianapolis, IN)
- …determined to make life better for people around the world. **Position Overview** Drug Product External Manufacturing (DPEM) Quality Assurance assures ... patients worldwide of safe and efficacious drug products, through effective quality oversight of...responsible for assuring the CM maintains a state of control with regards to manufacturing and/or packaging… more
- Lilly (Indianapolis, IN)
- …- $222,200 **Responsibilities:** The Senior Director, Drug Product External Manufacturing (DPEM) - Quality Assurance (QA), provides leadership of the ... DPEM and CM compliance with Good Manufacturing Practices (cGMPs) and Quality Standards, including validation, change control , deviations, complaints, APRs, … more
- Amgen (Thousand Oaks, CA)
- …Supply manufacturing . + Define, drive, and deliver the automation and process control strategies within Drug substance manufacturing . + Serve as an ... and transform the lives of patients while transforming your career. Senior Manager Manufacturing Systems ( Drug Substance Automation) **What you will do** Let's… more
- Parker Hannifin Corporation (Irvine, CA)
- Manufacturing Engineer I - Military Flight Control Division Location : IRVINE, CA, United States Job Family : Mfg & Prod Engineering Job Type : Regular Posted : ... machine parts and assemblies; ensures that products and processes meet customer quality requirements. Provides producibility input and manufacturing plans for… more
- Lilly (Philadelphia, PA)
- …around the world. **Responsibilities** This role is responsible for providing daily quality oversight at the Contract Manufacturer (CM) site. This role is located ... assistance, and guidance to issues such as deviation investigations, change control proposals, procedure/ master formula revisions, and other duties associated with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …help create possible, together. **Job Description** Senior Manager, Global External Manufacturing , Sterile Drug Product manages uninterrupted supply of Gilead's ... **Qualifications** : + Demonstrated track record in sterile small or large-molecule drug product manufacturing and supply chain execution and oversight in… more
- Lilly (Indianapolis, IN)
- …process control strategy including the key process parameters, critical quality attributes. + Understanding product history and potential failure modes of the ... as required. + Ensure that there is an accurate, control strategy, process parameters and critical quality ...influence CMs. + A thorough understanding of cGMPs and drug product manufacturing . + Good communication skills,… more
- BeiGene (Hopewell, NJ)
- …to ensure a successful facility, equipment, and process start-up; improve process control , yield, and product quality and/or productivity. This will include ... the development and implementation of processes, systems, and facilities related to drug substance manufacturing , key intermediates eg, media and cleaning… more
- Cambrex High Point (Waltham, MA)
- …and commercial settings, with a strong preference for those with a technical background in manufacturing or Quality Control (QC). This role offers a unique ... Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance,...EMA, and ICH guidelines. + Strong technical background in manufacturing or Quality Control (QC)… more
- Curia (Albuquerque, NM)
- …understanding of laboratory, manufacturing , packaging, regulatory, compliance, and quality assurance requirements for biological and drug product ... Manager, Manufacturing Quality Assurance in Albuquerque, NM...needed. + Provide support on validation report closure, change control , investigation approval and other QA systems related issues.… more
- GE Aerospace (Wilmington, NC)
- … quality assurance and quality control . It includes quality assurance of products, services, and manufacturing processes. It includes conformance in ... **Job Description Summary** The Rotating Parts Advanced Manufacturing Quality Engineer will work within... manufacturing , incoming goods control , product inspection, witness points, etc, including responsibility for… more
- GE Aerospace (Lynn, MA)
- …both quality assurance and quality control + Includes quality assurance of products, services, manufacturing processes + Manage conformance in ... manufacturing , incoming goods control , product inspection, witness points, etc. + Lead analytical... or quality ) + 3 years of manufacturing quality shop floor experience in regulated… more
- Parker Hannifin Corporation (Cleveland, OH)
- Parker Leadership Development Program- Quality Manufacturing Engineer Associate Location : Cleveland, OH, United States Job Family : Support Job Type : Regular ... criteria: + Bachelor of Science in Engineering with a focus in Quality , Manufacturing , Industrial, Chemical or Mechanical Engineering + Graduation before… more
- GE Aerospace (Lynn, MA)
- …both quality assurance and quality control . Includes quality assurance of products, services, manufacturing processes. Includes conformance in ... **Job Description Summary** Product quality review associated with the manufacturing ...manufacturing , incoming goods control , product inspection, witness points, etc. + Broadening knowledge… more
- Lilly (Lebanon, IN)
- …providing technical support for the development, implementation, and technical transfer of compliant manufacturing of gene therapy drug substance and drug ... and the process), have strong working skills on the manufacturing equipment set and control systems, and...and improvement) + Understand the scientific principles required for manufacturing AAV drug substances and products, including… more
- Amgen (Thousand Oaks, CA)
- …operational shift support for Upstream and Downstream Drug Substance manufacturing . + Experience in change control , nonconformance, corrective & preventative ... the Principal Manufacturing Systems Engineer will ensure the success of Drug product manufacturing through an extensive understanding and solid background in… more
- Amgen (Thousand Oaks, CA)
- …and technologies. + Collaborates with Manufacturing , Combination Product Operations, Quality , and Regulatory partners to manage change control processes and ... manufacturing facility. The specialist will serve as the clinical manufacturing operations representative for various Final Drug Product teams throughout… more
- Amgen (West Greenwich, RI)
- …equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility. + ... the lives of patients while transforming your career. **Principal Manufacturing Systems Engineer** **What you will do** Let's do...various automation systems and platforms that support the GMP Drug Substance Plant Operations. In this vital role as… more
- Saint-Gobain (Solon, OH)
- …enormous impact of our efforts on the world around us. **The Sr. Design Quality Engineer is responsible for supporting quality engineering activities to support ... life cycle, from concept to commercialization.** **Will serve as the key quality resource on the cross functional new product development teams for ensuring… more
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