Displaying 1-5 of 5 results
Principal Specialist, Regulatory CMC
Amylin Pharmaceuticals, Inc - Cincinnati, Ohio
Pharmaceutical
Job Title: Principal Specialist, Regulatory CMCProfession: Biotechnology/Pharmaceuticals -> Clinical Development ProfessionalsBased at our manufacturing facility in West Chester, Ohio and reporting in to our headquarters in San Diego, this position is responsible for providing full time on-site regulatory support at Amylin Ohio LLC to facilitate successful product launch and implementation of post-approval chemistry, manufacturing controls (CMC) changes related to exenatide microsphere product life cycle management. Extensive engagement and interaction with Amylin manufacturing, (see more)
Cleaning Validation Engineer
Amylin Pharmaceuticals, Inc - Cincinnati, Ohio
Manufacturing
Job Title: Cleaning Validation EngineerProfession: Engineering and Science -> Manufacturing EngineeringPlan and schedule validation projects, including the ability to develop, perform, maintain, and support validation activities and documentation in accordance with cGxP requirements. Provide support to the Amylin Quality department for regulatory inspections and audits. Responsibilities: Maintains all documentation pertaining to qualification and validation. Generates validation plans. Develops/reviews requirements and specifications. Able to follow-up and resolve (see more)
QA Analyst, In-Process Support
Amylin Pharmaceuticals, Inc - Cincinnati, Ohio
Pharmaceutical
Job Title: QA Analyst, In-Process SupportProfession: Biotechnology/Pharmaceuticals -> QA/QC and AuditingResponsible for review and/or approval of batch specific manufacturing documentation as part of the lot disposition process according to established written procedures for the Amylin Ohio LLC site. This position will be scheduled for the night shift, with required weekend work. Responsibilities: Provide QA support for the manufacturing function by facilitating quality investigations, and performing real-time review of critical documents within the Operations area Perform (see more)
Microbiology Analyst
Amylin Pharmaceuticals, Inc - Cincinnati, Ohio
Pharmaceutical
Job Title: Microbiology AnalystProfession: Biotechnology/Pharmaceuticals -> QA/QC and AuditingAssure products adhere to Amylin Pharmaceuticals, Inc. standards as well as those of the agencies that regulate the pharmaceutical industry around the world. The QC Microbiologist applies expertise in microbiological control strategies and implementation including ID, environmental monitoring, sterility, particulate, endotoxin, bioburden, and biological indicator disciplines. Support testing of raw material, in-process, finished product, and stability laboratory samples. Responsibilities: (see more)
Process/Manaufacturing Engineer-Reliability
Amylin Pharmaceuticals, Inc - Cincinnati, Ohio
Manufacturing
Job Title: Process/Manaufacturing Engineer-ReliabilityProfession: Engineering and Science -> Manufacturing EngineeringWork with Maintenance/MRO Manager to support reliability engineering and equipment improvement efforts in a Pharmaceutical Plant involved in the production of active pharmaceutical ingredients, aseptic filling operations, and finished product packaging and inspection. This position is responsible for developing the overall asset management strategy for assigned equipment. RESPONSIBILITIES: Provide technical support for a pharmaceutical manufacturing operation. (see more)

Displaying 1-5 of 5 results

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