SGS_JOB_1016
Contract - 6 Months+ (Potential Extension)
Accountable for developing and implementing labeling content and strategy for multiple drug development products, including TLPs, CCDS, USPI, and EU SmPC. Manages Labeling Cross-Functional Teams, fostering collaboration and aligning labeling strategy and content. Interfaces with Senior Management (GLOC) to secure labeling approval, ensuring alignment and preparation of GLOC Chair(s) and members. Works closely with the Head of Global Regulatory Affairs Marketed Products and Labeling.
Location (mandatory): Tucson, AZ (1st or 2nd shift) Supports the functions of RTD histology laboratories in the performance of routine histotechniques. This is an essential position supporting the organizational goals requiring attendance on weekends, holidays and during emergency or exceptional conditions.
Travel Requirements: Limited as job tasks are required The Clinical Programming Manager is responsible for managing the timely and accurate execution of programming components of clinical trials. The Manager leads and manages completed projects that involve global tasks, cross functional teams, or outsourcing resources. The role may require providing input to design and analysis, and reporting the results of clinical trials, including programming rules and mocked T/L/G. In addition, providing all safety claims for new drugs and extension of claims/publication support for our marketed drugs.
Location: Davie, FL 33314 This position is responsible for planning, managing, and executing projects and teams at the Davie site and interacting with other project managers across network. These projects include, but are not limited to process changes, equipment qualification, new equipment, software, automation, and system implementation, etc. This individual will work with cross-functional teams at the site, and at other internal and external locations.
This position supports the execution of routine testing in the Quality Control Analytical Chemistry laboratory, including chemistry assays associated with Incoming Quality and Raw Materials. This position requires proficiency and understanding of the theory related to processes, assays, and equipment, as well as the ability to identify issues/trends. The candidate filling this position will work to ensure tasks are completed in a timely manner, while strictly adhering to policies and procedures and cGMP.
Location (mandatory): Princeton/Plainsboro, NJ Contract (mandatory): 6 months Pay Rate (optional): $25.00 Shift timing: Shift: Hours - 08:30 am - 04:45 pm Friday early release - (Pending time) Organization Skills the ability to work individually and with the team. Strong Math skills required (converting recipes to grams and percentages) Knowledge of Commercial food & Beverage processing
Location (mandatory): Portsmouth NH The Manufacturing Associate Level I is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level I associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials.
Location (mandatory): Houston TX The Environmental Monitoring (EM) Core Technician will be responsible for conducting EM tasks in support of production and aseptic processing of clinical grade products. The core tech will also be responsible for maintaining, stocking, and set-up of clean room environment.
This position supports the execution of routine testing in the Quality Control Analytical Chemistry laboratory, including chemistry assays associated with Incoming Quality and Raw Materials. This position requires proficiency and understanding of the theory related to processes, assays, and equipment, as well as the ability to identify issues/trends. The candidate filling this position will work to ensure tasks are completed in a timely manner, while strictly adhering to policies and procedures and cGMP.
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