Deviations Writers – CAPA/Process Engineers – Batch Record Reviewers (232137) Harmans, MD

Northeast, United States

Our client is looking for several consultants to come in and assist with the backlog of deviations they need done by mid- February the latest. They will be needed for the operations piece for deviation support, they already have a team of QA folks to support the closure of the deviations so they will be needed primarily for manufacturing operations deviations.
NH: Process Engineer Utilities (232497)

Northeast, United States

NH: Process Engineer Utilities (232497) Our client is looking for a Process Engineer for a 6+ month assignment who has a strong Utilities background, specifically with boilers. Utilities focused for the project with Project Management experience being a strong plus.
EO Sterilization Project Manager (232913) Remote

Remote, United States

Our medical device client is qualifying 2 new vendors, one in Utah and one in California to preform EO sterilization on their products. They need an individual with EO sterilization validation experience and project management experience to oversee the process. This individual will need to work with both vendors as well as the internal team to build out the current demand of EO chambers as well as a scalable solution based on increased future needs. The right candidate will be able to understand the timing of validations and scalability of each vendor to match the increased demand of EO sterilization so it is seamless scalability. This individual will need to understand EO validation process as well as potentially be hands on in reviewing and approving the validation packages for additional EO chambers being validated.
Remote: QC Analytical Method Validation (232907)

Remote, United States

Remote: QC Analytical Method Validation (232907). Our client is currently looking to bring on a QC analytical consultant to help with
Medical Writer (Neurovascular) (232877) Remote

Remote, United States

Our client is looking for a Medical Writer specifically focused in Neurovascular Medical Devices. This person main responsibility will revolve around Protocol and CSR Review, Editing, and Finalization. It would also be great if this writer has a background in CER, CEP and Annual reporting writing as this will be the focus after the protocols are submited at the end of May.
NC: Quality Engineer, Validation (232848)

South, Southeast, United States

NC: Quality Engineer, Validation (232848) Our client is seeking a Quality Engineer for a 36 month assignment. 4 filing lines client is getting ready for the first submission and there is a lot of support needed to support quality of the PV process as well as transfer activities
Business Analyst (BLA/IND Filing) (232807) MA

Northeast, United States

Client is looking for a senior Business Analyst who comes with significant Biologic experience for early development BLA/IND filing projects
Remote with up to 20% travel to TX: Regulatory Info Mgmt System Consultant

Remote, South, United States

Remote with up to 20% travel to TX: Regulatory Info Mgmt System Consultant. Client is looking for a Consultant to build and implement a
GA: Drug Product Process Engineer (232289)

South, Southeast, United States

GA: Drug Product Process Engineer (232289) Client is looking for someone with a filling and lyophilization equipment background for the buildout project. Managing Factory Acceptance Testing, development and implementation of all filling equipment SOPs, maintenance procedures and risk assessments.
Hybrid in PHX: ERP Logistics Program Manager

Southwest, West Coast, United States

Hybrid in PHX: ERP Logistics Program Manager. Our client is seeking a Senior Program Manager for a Global Enterprise management project
NY: Existing Building Construction PM (232766)

Northeast, United States

NY: Existing Building Construction PM (232766) Our client is looking for 2 Existing Building Project Managers for a 24 month assignment for construction projects. These are all GMP focused and involves a mix of projects in size and scope.
Remote: Regulatory Affairs Specialist (NDA) (232763)

Remote, United States

Remote: Regulatory Affairs Specialist (NDA) (232763) Our client is looking for a strong Regulatory Affairs specialist for an 18 month assignment that has strong work ethic to work remote and hit deadlines.