QA & QC Engineer Salary at Moldflow Corp BETA

Our Mission: In a world where drug development is an incredibly slow and inefficient process, we enable the biopharma industry to advance drugs faster and easier than has ever been possible with our simple, tech-driven platform that delivers critical capabilities quickly and with consistently high quality. . Company Summary: Now out of stealth, Dash Bio takes a technology-first approach to developing critical services across the drug development lifecycle. The company is building new capabilities that leverage AI, robotics, and fully-integrated software to fundamentally reinvent the way drugs are brought to market. Our first capability is a highly-automated clinical bioanalysis lab that promises to deliver GLP-compliant services with unprecedented speed. Dash is led by an ambitious team of industry pros aligned on a shared vision and ethos. Founders include Dave Johnson (CEO), former Chief Data & AI Officer at Moderna; Ander Tallett (COO), CEO and founder of DigitalRadius and an experi

JOB SUMMARY: We are seeking an Electrical Engineer Manufacturing who will be responsible for supporting the operational deliverables of multiple organizations within the Doble Community (Manufacturing Operations, Quality, Purchasing, Engineering, and Customer Care). The Electrical Engineer Manufacturing is recognized as an expert in the principles and application of sustaining engineering, DFX, DFM, quality assurance and compliance relating to electromechanical manufacturing. The Electrical Engineer Manufacturing is familiar with the importance of providing feedback throughout the managed processes assuring process control and compliance of materials and products manufactured internally and externally. The Electrical Engineer Manufacturing coordinates or executes activities on multiple complex projects and takes a role in the design, qualification and execution of new projects. The Electrical Engineer Manufacturing adapts to multiple projects, effectively ensuring alignment with corpor

**Compliance Specialist** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com . **Astellas Institute for Regenerative Medicine (AIRM)** is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medi

**Technical BioPharma Manufacturing MSAT Engineer MA-TC** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com . **Astellas Institute for Regenerative Medicine (AIRM)** is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of

Overview: The QC Inspector I report directly to the QC Inspector Lead, QA Manager or Director. This position is responsible to actively participate in the Repligen ISO 13485 Quality Management System. This role is responsible for inspecting, auditing, and reporting on incoming materials and processes using various visual techniques and measuring equipment to ensure conformance to the organization and customer quality standards. Responsibilities: Mechanical inspection of incoming product from suppliers according to documented processes. Includes physical inspection and paperwork inspection to verify conformance to requirements. Requires demonstrated use of mechanical inspection hand tools and CMM, FARO a plus. Mechanical inspection is performed on machined parts based on drawing requirements using precision measuring tools Electronics inspection will include verification of components to engineering records, documentation requirements. Identify and document results of inspections. Clear

RESEARCH SCIENTIST II, CELL LINE PROCESS DEVELOPMENT in Hopkinton, MA Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. We are rapidly growing and seeking a talented individual for the role of Research Scientist II to join our Process Development team based on Hopkinton, MA. The successful candidate will be able to lead and execute laboratory procedures and perform stable cell line development and expression of recombinant proteins and antibodies to support manufacturing. Strong candidate will have extensive experience in mammalian cell culture engineering to develop highly productive upstream processes. Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients lives with the pharmaceuticals we develop and manufacture. We proudly offer + Generous benefit options (eligible first day of employment)

The CMC QA Consultant will report to the Senior Director of CMC QA and be responsible for supporting cross functional team (i.e. PD, MSAT, CMC, Manufacturing, Regulatory Affairs etc) to confirm the appropriate quality as well as compliant controls are in place for assigned Gene Therapy programs, and working with colleagues to improve processes utilized to ensure product quality. In this role, in collaboration with key stakeholders in Technical Operations, Regulatory Affairs and extended Quality (ie. QC, Supplier Quality), you will provide Quality oversight and support to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines at GTMF and/or contract manufacturing organizations (CMO). Duties/Responsibilities: Quality Assurance Lead for the cross-functional CMC Sub-Teams Provide quality oversight of process performance qualifications and associated studies Support review and approval of proce

Responsibilities: Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions. Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations. Reviews and approves Quality, Quality Control, Validation and Automation related documents Review and approve Standard Operating Procedures (SOPs). Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and summary reports. Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements. Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation. Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working environment. Able t