- Kedplasma (Cinnaminson, NJ)
- …Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make your job ... description as complete as possible. However, that in no way states or implies that these duties/responsibilities are the only duties you will be required to perform. The omission of specific duties/responsibilities does not exclude them from the position if… more
- Amcor (Monroe Township, NJ)
- …immediately. Reports accidents to the supervisor immediately. Follows site cGMP and Safety requirements. Performs other duties as assigned. **Qualifications** ... **Qualifications:** **Skills** Must have the ability to remember packing sequence and pack patterns. Ability to carry out work orders, make decisions on bottle jams. Must be able to meet deadlines. **Education and/or Equivalent Experience** Basic math skills.… more
- AbbVie (Branchburg, NJ)
- …job duties and responsibilities. * Responsible for maintaining adherence to cGMP requirements (training, documentation, procedures, etc.) for the department. * ... Supports the department manager in the development of budgets and assists with monthly financial tracking. Supports the department manager in developing Key Performance Indicators for the organization, tracks data related to KPI's, and drives improvement… more
- Roche (Branchburg, NJ)
- …in IVD, Pharmaceutical, and /or Medical Device industry; Regulatory Compliance, Federal cGMP 's and QSR's, ISO13485 and 27001. + Experience with global submissions ... for US FDA (Class 1-3), EU Notified Bodies (Class A-D), and International (including China) + Strong track record of building and nurturing capabilities such as technical regulatory knowledge, strategic thinking, verbal and written communication and… more
- System One (Allendale, NJ)
- …Analytical team supporting cell therapy. Oversee day-to-day lab operations, ensure cGMP compliance, maintain audit readiness, and manage staff performance. Hands-on ... with CBC, Endotoxin, ELISA, qPCR, and quality records. What You'll Do: + Supervise, coach, and develop QC staff + Approve investigations and OOS documentation + Maintain compliance with FDA/EU regulations + Drive process improvements and KPI achievement +… more
- System One (Park Ridge, NJ)
- …stages and aspects of development (preclinical, clinical, and commercial) and cGMP industrial background + Excellent communication skills (verbal / written); Ability ... to explain science to management + Identifies opportunities and takes risks to achieve objectives + Simplify complex ideas, collaborate effectively, deliver results, and innovate in sterility assurance + Able to work on multiple projects of varying complexity… more
- Robert Half Technology (Bridgewater, NJ)
- …and related processes in accordance with industry standards (including AATB, FDA, cGMP ) + Develop and update detailed project plans, timelines, budgets and resource ... allocations + Lead weekly project team meetings to communicate project status, updates and milestones to the project team and executive management. + Collaborate with internal stakeholders and external partners + Drive accountability for project deliverables +… more
- Integra LifeSciences (Plainsboro, NJ)
- …and control systems related to manufacturing and utility equipment in a cGMP medical device manufacturing plant. Such equipment may include but is not ... limited to: + Manufacturing Process Equipment (Autoclave Sterilizers, Mills, Mixers, Sealers, Washers) + Facility Equipment (Clean Compressed Air, Heating Hot Water, Clean Steam, Plant Steam, Waste Treatment, WFI Generation) + Refrigeration Equipment… more
- AbbVie (Branchburg, NJ)
- …with high attention to detail, while practicing Current Good Manufacturing Practices ( cGMP ) in an FDA regulated environment Qualifications + High School diploma or ... GED required. Minimum of 4 years' experience as a Senior Instrument Technician or the equivalent. Associates Degree in electronics technology or equivalent is strongly desired. College course work and/or ASQ Certified Calibration Technician (CCT) certificate a… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …to ensure operational excellence, equipment reliability, and compliance with cGMP standards. Essential Functions: + Develop, implement, and optimize preventive ... and corrective maintenance programs to maximize equipment uptime and reliability. + Diagnose and resolve complex mechanical, electrical, pneumatic, hydraulic, and automation-related failures independently. + Lead the maintenance, troubleshooting, and repair of… more