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We are looking for Aseptic Technician for our client in Ridgefield, NJ
Job Title: Aseptic Technician
Job Location: Ridgefield, NJ
Job Type: Contract
Job Description:
Pay Range: $25hr - $30hr
Responsibilities:
We are looking for Aseptic Technician for our client in Ridgefield, NJ
Job Title: Aseptic Technician
Job Location: Ridgefield, NJ
Job Type: Contract
Job Description:
Pay Range: $25hr - $30hr
Responsibilities:
- Perform aseptic gown qualification and maintain the gown qualification at scheduled intervals.
- Participate in the aseptic media simulation at scheduled intervals as per regulatory requirements.
- Performs the tasks of the production operation specific to intermediate aseptic bulk manufacturing (collection and extraction hyaluronic acid (HA) and Aseptic Fluids/bulks and Gels) and Filling.
- Maintains batch record documentation and logs as required by corporations and regulatory agencies.
- Must be able to perform cleaning and sanitize production equipment and classified production space.
- Prepare equipment, filters, etc. required for production.
- Assists in process and system validation activities as required.
- Performs product sampling, environmental monitoring, or other related activities as directed.
- Serve as witness to routine unit operational tasks for batch record signing. Maintains all associated documentation for operations being performed.
- Demonstrates ability in applying requisite skills and acquired knowledge while following established practices and procedures.
- The physical demands described here are representative of those an employee must meet to successfully perform the essential functions of this job.
- Most of the work activities are performed while standing.
- Based on Business needs and production schedules, random and different start time scenarios may occur, so a very flexible work schedule is required for the candidate. Ability to accommodate production requirements that may require 50 hour workweeks.
- This role requires frequent work on weekends depending on production demands.
- Upon business needs, independently performs routine tasks in the areas of Formulation, Filling, and packaging operation.
- This job will require the transfer of heavy vessels on wheels and autoclave racks on wheels.
- It is required that individuals care for their own safety and wellbeing. Individuals must promote a safe working environment for employees and contractors working in their area of responsibility.
- The individual must support all Sanofi and site HSE policies and ensure that work performed complies with local HSE regulations.
- Individuals must complete all required HSE training.
- Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility.
- Individuals must ensure timely closure of HSE actions owned by their departments.
- Perform routine daily and weekly cleaning of manufacturing area.
- Perform to ensure compliance with GMPs and SOPs.
- Will receive instructions on all assignments with some supervision.
- Takes initiative to identify issues, troubleshoot, propose solutions, and keep leads/ management informed.
- Requires good documentation skills and attention to detail.
- Basic computer skills preferred.
- Ability to work with aseptic gown up for about 80% of the shift working hours.
- Ability to offload products off carts and onto pallets; move transfer carts in and out of manufacturing area.
- Ability to stand over intervals of several hours at a time.
- Ability to bend, squat, and reach.
- Ability to lift, push, or pull various amounts of weight.
- Ability to clean and sanitize process equipment and rooms.
- Ability to complete tasks and training in a cGMP environment.
- Ability to work in both individual and team environment.
- Ability to enter into confined Space. (Approx. 1-2 hr./week) as needed.
- 2 years of related experience in Pharmaceutical Manufacturing with a minimum of 2 years ofexperience in a GMP regulated environment.
- Knowledge in CGMP/regulatory compliance.
Salary : $25 - $30