MD: QC Scientist- Experimental (2 Spots) (232214)

Mid-Atlantic

MD: QC Scientist- Experimental (2 Spots) (232214) Our Pharmaceutical client is looking for a QC Scientist to perform analytical development, verification, validation, and routine quality control operations, to evaluate the quality of products through testing and to support Quality Unit activities
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.
PA: Quality Assurance Specialist (232207)

Mid-Atlantic

PA: Quality Assurance Specialist (23207) Our client is need of a Quality Assurance Specialist to come on for 4-6 month plus assignment, PA. Our client has a new GMP plant with a lot of activities going on as well as merging multiple sites and systems. This person will be responsible for Quality Deviations, Change Control, CAPA work and Root Cause Analysis. It would be helpful to have experience with doc control. This person must come from a risk management background.
PA: Sr. Validation Contractor (232206)

Mid-Atlantic

PA: Sr. Validation Contractor (232206) Our client is need of a Validation Contractor to come on for 4-6 month plus assignment, PA. Our client has a new GMP plant with a lot of activities going on such as IQOQ, this person will be responsible for process validation, equipment validation and cleaning validation.
NJ: QA Batch Record Review (232193)

Mid-Atlantic

NJ: QA Batch Record Review (232193) The company is a 503b compounding facility that is operating under FDA rules/regulations. The client is having trouble with GMP requirements and need to stay compliant. Currently they are under a warning letter for not meeting GMP standards. Although these contractors are not directly responsible for the remediation work—remediation experience is a plus.
Remote: Sr. External Quality Specialists (232186)

Remote

Remote: Sr. External Quality Specialists (232186) 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. Work is pertaining to management and oversight of the CMO’s and making sure they are running their systems within compliance. In the end this is the client’s product so need to make sure the resource has an eye for Quality and is able to oversee CMO activities as they relate to Quality Documentation; Batch Disposition Documentation, Change Control Documentation, Deviation Reports, etc. It would be great if candidates were out there who started in QC/Analytical and then moved into the QA Space. It would be even better if they had some Gene Therapy mfg experience. If they don’t have C&G Therapy, but have some QC Analytical that is the trade-off. Client is looking for a hard worker who has good work ethic and able to juggle multiple tasks at once. Not looking for managerial/Director level experience or process improvements. Need’s a good contractor to do the work.
CA: RA Specialist (232182)

West Coast

This candidate will be working on project teams for 2-3 new devices, including both new products (from the ground up) and next generation devices. This role will include heavy interaction with the NPD and R&D teams to drive compliance throughout product development. 
San Jose CA: RA Specialist (232182)

West Coast, United States

San Jose CA: RA Specialist (232182). Our San Jose based Medical Device Client is in need of a Regulatory Affairs Specialist to come onsite and
PA: Lab Director (231670)

Northeast, United States

PA: Lab Director (231670). The client is looking for a Lab Director with 10 years of CRO, Bioanalytical experience. This candidate will be
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
East coast: Global Trial Manager/Operations Lead (232176)

Mid-Atlantic, Northeast, Remote, Southeast, United States

East coast: Global Trial Manager/Operations Lead (232176). Our client is looking for a Sr. Global Trial Manager/Operations lead that is
Remote (Onsite visits in NJ as need be): Sr. CRA (232155)

Northeast, Remote, United States

Remote (Onsite visits in NJ as need be): Sr. CRA (232155). The CRA position will be responsible for tracking key study metrics, creating and