- Perform tasks of the production operation specific to bulk formulation and aseptic filling line support.
location: Ridgefield, New Jersey
job type: Contract
salary: $17.65 - 20.77 per hour
work hours: 3 to 11
- 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.
- This job will also entail transfer of heavy vessels on wheels and autoclave racks on wheels.
- Typical minimum education and experience required is AA degree in related discipline and experience working in GMP environment 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.
- Applies acquired skills while performing the most complex tasks of the position, following established practices and procedures. 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.
- 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, majority of the work activities are performed while standing.
- 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 stand for longer periods, bend, squat, and reach
- Ability to lift, push or pull various amounts of weight
- 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 extended day hours and weekend. Core Work hours are 3pm to 11:30pm. This role requires frequent work on weekends depending on production demands.
- 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.
- Experience: 0 to 5 years
skills: SOP, CAPA, 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.