Shift: 8am – 5pm or 7am – 4pm. Position will be onsite. Level of experience – Associate minimum. Must have qualities in a candidate – Attention to detail. If you have additional questions, please feel free to let me know. Duties. Reads original copy or proof to detect and mark any grammatical, typographical or compositional error. May also check dimensions, spacing and position for accuracy. Has knowledge of proofreading symbols. Requires minimal...
Individual needs to be onsite, at either our Temecula, CA location or Lillehei location in St. Paul. Contract duration is 12 months. Project Manager, Regulatory Intelligence. Primary Focus: EUMDR. Contract position. Now – June ’24. potential to extend. Responsible for project management for client Medical Devices implementation of EUMDR, through the final stages for EU certification, and our International roll out. Plans and directs schedules. Mo...
2-3 weeks onsite and then one day onsite per week until further notice. Position is till the end of 2024 and will extend in 2025 depending on work and performance. Looking for Project coordinator or supply chain candiate with SAP and data analysis and create reports exp. Local Candidates only. This is more of a business role. Not a biology, chemistry or science role. Associate degree needed minimum. Regulatory background will be helpful. Customer...
No C2C please. Responsibilities. Well versed in performing CMC compliance activities including Gap Analysis. assessment for Annex 3 comparative table with reference EU Member States. Manage execution / authoring and review of CMC documentation (Module 1 , 2 and 3 / Part II ) for life cycle management - post-approval supplements, baseline dossiers, annual reports, registration renewals, response to health authority questions, assessment reports an...
6 Months (potential to extend to 12). Interview process. In person interview. 2 Open roles. Start time is 7:00 AM or 8:00 AM (First shift role). Will be doing testing on Water samples, room sampling and microbial testing. Open to interview candidates graduating in may as well. Bachelor’s Degree minimally required, Associate’s Degree with at least 2 years of lab experience, High School Diploma with at least 5 years of directly related lab experien...
Notes. Help create a project management structure for Supply chain related projects. Supply chain areas in scope: Purchasing, Production planning, Warehouse. Would be responsible for ~ 50 – 100 different projects across the supply chain area ranging in complexity. Project scope/complexity range from 2-9 months in duration. Maintain project templates, Coordinate/run project meetings, track actions and follow up with action owners, create and maint...
Duties. Provide in-depth statistical expertise in the areas of experiment, protocol, case report form design, data base structure, and analysis plan. Collaborate with the medical groups to complete joint scientific reports and FDA overviews, including review of such reports to ensure accuracy and clarity. May also contribute to the decision for optimal study design and contribute to the proper use of statistical methodologies for a study. Must ha...
This role will liaise with R&D Training management to support the maintenance of assigned training plans and will also work closely with GxP Training in Quality Systems. Participate in inspection readiness activities and may support inspection and audit training SMEs. and may assist in special projects as assigned by the R&D Training department management. Job Type: Contract. Pay: $30.00 per hour. Expected hours: 40 per week. Benefits. 401(k). 40...
This role will liaise with R&D Training management to support the maintenance of assigned training plans and will also work closely with GxP Training in Quality Systems. Participate in inspection readiness activities and may support inspection and audit training SMEs. and may assist in special projects as assigned by the R&D Training department management. Job Type: Contract. Pay: $30.00 per hour. Expected hours: 40 per week. Benefits. 401(k). 40...
The position of Regulatory Affairs Specialist II is within our Infectious Disease business unit. In this role you will prepare documentation for EU Technical Files and international product registrations. Onsite role. IVDR exp is a must. No Hybrid work involved. No travel involved. Local candidates first. Open for candidates who has 3 - 4 yrs. of IVDR exp and overall 4 yrs. exp in regulatory affairs and are ready to relocate at their own expense....
Onsite role 100%. Shift : Shift : 7 AM - 8:00 AM -2:30 PM or 3:30 PM. Incoming QA tech roles. Master’s degree is overqualified. Require lifting of cases from 30 -50 pounds. Visual inspection. 1-2 yrs exp with High school. High School Diploma or associate degree will work. Forklift would be used to get to materials and put them back to location. Previous SAP experience. Evaluate results. Sample inspecting and testing of incoming commodities. Print...
6 Months (potential to extend to 12). Interview process. In person interview. 2 Open roles. Start time is 7:00 AM or 8:00 AM (First shift role). Will be doing testing on Water samples, room sampling and microbial testing. Open to interview candidates graduating in may as well. Bachelor’s Degree minimally required, Associate’s Degree with at least 2 years of lab experience, High School Diploma with at least 5 years of directly related lab experien...
