Aseptic Technician II will independently perform the tasks of the aseptic manufacturing operation specific to bulk manufacturing. This includes collection and extraction hyaluronic acid (HA) and intermediate bulk manufacturing process for medical device products along with pharmaceutical based products. In support of our main functions, additional responsibilities include cleaning and sanitization of aseptic manufacturing facility and process equipment.
location: Ridgefield, New Jersey
job type: Contract
salary: $25 - 30 per hour
work hours: 9 to 5
education: High School
responsibilities:
- Perform aseptic gown qualification and maintain the gown qualification at schedule interval. Participate the aseptic media simulation at schedule interval 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 Manufacturing).
- Maintains batch record documentation and logs as required by corporation and regulatory agencies. Must be able to perform cleaning and sanitizing of production equipment and classified production space. Prepares 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.
- Demonstrated ability in the application of requisite skills and applies additional skills and acquired knowledge while following established practices and procedures.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Most of the work activities are performed while standing.
- Based on 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, including 2nd shift or split shift hours, extended day hours and weekends. 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 also requires the transfer of heavy vessels on wheels and autoclave racks on wheels.
qualifications:
Skills:
- Perform routine daily and weekly cleaning of manufacturing area.
- Perform to ensure compliance with GMPs and SOPs.
- Will receives instructions on all assignments with supervision.
- Takes initiative to identify issues, troubleshoot, propose solutions, and keep leads/ management informed.
- Primary first shift position (including 2nd shift or split shift hours, extended day hours and weekends).
- Ability to work with aseptic gown up for about 80% of the shift working hours.
- Ability to offload product 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
- High School Diploma
- 1 year of related experience in Pharmaceutical Manufacturing with a minimum of 1 year of experience in a GMP regulated environment
- Knowledge in CGMP/regulatory compliance.
skills: SOP Development, Good Manufacturing Practices (GMP)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
