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location: Ridgefield, New Jersey
job type: Contract
salary: $17.65 - 20.77 per hour
work hours: 3 to 11
- Perform tasks of the production operation specific to bulk formulation and aseptic filling line support.
- Maintains batch record documentation and logs as required by corporation and regulatory agencies.
- Performs cleaning and sanitizing of production equipment and classified production space.
- Prepares, according to procedures, various stock solutions and buffers as required by the production process.
- Prepares equipment, glassware, filters, etc. required for production. Assists in process and system validation activities as required.
- Independently performs product sampling, environmental monitoring, or other related activities as directed.
- Independently performs routine tasks in the areas of Aseptic Syringe Filling.
- This includes but it is not limited to Operation of the syringe filling while monitoring critical parameters as per procedures. T
- This job will also entail transfer of heavy vessels on wheels and autoclave racks on wheels.
- Experience: 0 to 5 years
- Associate's Degree (Community College, MBO)
- Prior document revision (SOPs and BPRs) experience and experience reviewing BPRs is preferred.
- Prior mechanical experience and experience working as an Aseptic Production operator is preferred
- Will serve as witness of routine unit operation tasks for batch record signing. Maintains all associated documentation for operations being performed.
- Will be assigned formal FMEAs, RAs, CAPAs, CCRs, NCRs, and Action Items as needed.
- Demonstrated ability to apply experience to perform equipment troubleshooting, monitor employee activities and to make procedural revisions, as needed. Implements and maintains production schedules based upon intra-departmental information.
- Perform to ensure compliance with GMPs and SOPs.
- Receives instructions on all assignments with supervision.
- Takes initiative to identify issues and keep leads / management informed.
skills: GMP (Good Manufacturing Practice), Manufacturing Operations
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.