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location: Ridgefield, New Jersey
job type: Contract
salary: $25 - 30 per hour
work hours: 3 to 11
education: Bachelors
responsibilities:
Aseptic Technician Associate will independently perform the tasks of the aseptic manufacturing operation specific to bulk, and fill manufacturing. This includes collection and extraction of hyaluronic acid (HA), HA gel manufacturing, Buffer and Saline production, intermediate bulk manufacturing, filling, inspection, and packaging 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.
Job Responsibilities
- Perform aseptic gown qualification and maintain the gown qualification at schedule interval. Participate in 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) 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.
- Demonstrated ability in the application of requisite skills and applied 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.?
- This job requires working primarily in 2nd shift, split shift hours, late extended day hours and weekends. 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.
qualifications:
- 2 years of related experience in Pharmaceutical Manufacturing with a minimum of 2 years experience in a GMP regulated environment
- Knowledge in CGMP/regulatory compliance
- Basic computer skills
skills: SOP Development, Regulatory Compliance, 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.
