Remote: Senior Supplier Quality Engineer (232212)

Remote

Remote: Senior Supplier Quality Engineer (232212) Our client is looking for a 10+ year Senior Quality Engineer with a career focused in Medical Devices. Supplier Quality experience: evaluation and gap assessment of existing process, recommendations for changes (SOP, WI and template levels), change execution, training, can draft Supplier Quality Agreements and work through these with critical suppliers.
Remote: Regulatory PM (232208)

Remote

Remote: Regulatory PM (232208) Our biotech client needs a Regulatory PM, ideally with significant experience with getting filings organized and sent out to the FDA. Potential EMA or member nations of Europe submissions but primarily FDA. Supporting one program around an asset they have acquired. Managing timelines and deliverables, version control, working on 1 major IND submission for Q1.
Hybrid in Loveland Colorado: Quality Engineer (232202)

Northwest, Remote, Southwest, West Coast, United States

Hybrid in Loveland Colorado: Quality Engineer (232202). Our client is looking for a Quality Engineer to come on-site for a 6 month plus
Remote: Fill Finish Consultant- Scale up (232200)

Remote

Remote: Fill Finish Consultant- Scale up (232200) Client is looking for a Fill Finish Consultant to work on writing a comparability study and protocol for scale up and facility/technical transfer for a small molecule peptide that is lyophilized. They have a product getting ready for scale up with the first PPQ batch in March of 2023.
Remote: Non-Clinical Writer (232188)

Remote

Remote: Non-Clinical Writer (232188) Our Client is looking for a Non-Clinical Medical Writer with at least 5 years of writing experience and 2 years of Ohpthomology experience. In addition to writing this professional will develop Non-Clinical FDA responses for the clients early phase clinical study. The day to day will also consist of authoring Non-Clinical development plans, protocols and results review of the study.
Hybrid in Lynchburg VA: Hardware Engineer (232190)

Mid-Atlantic, Remote, United States

Hybrid in Lynchburg VA: Hardware Engineer (232190). Need engineer (Electrical Engineering, Systems Engineering, Physics, or similar) to
Remote: Validation Engineer (232185)

Remote, United States

Remote: Validation Engineer (232185). Our Pharmaceutical Client is in need of a Sr. Validation Engineer with at least 5-7 years of experience.
Remote: Sr. External Quality Specialist (232186)

Remote

Client is in the gene therapy space and is looking for a contract resource to step in and help them in the External Quality and Compliance space. There is only 1 other person in this group at the time and manager needs to bring in another experienced resource who can help manage the workload. Extensive volume of change controls, batch record review, deviation work coming from their CMO’s
Hybrid 25% onsite in CO: Serialization SME (232126)

Remote, Southwest, United States

Hybrid 25% onsite in CO: Serialization SME (232126). Our Pharmaceutical client is looking for a senior level Serialization consultant with at
Remote: Regulatory Training Creation (232180)

Remote, United States

Remote: Regulatory Training Creation (232180). Client is looking for a contractor to come in and help create and revise their regulatory
Remote: Regulatory CMC Manager (232178)

Remote, United States

Remote: Regulatory CMC Manager (232178). Our client is looking for a Regulatory CMC Manager with around 5 years of experience to provide
Remote: Supplier Quality PM (232177)

Remote, United States

Remote: Supplier Quality PM (232177). Our Medical Device Manufacturer has growing portfolio of products that need to meet external regulatory