Manufacturing Associate III (Aseptic) - Rotating 1st & 2nd Shift

Amneal Pharmaceuticals

Chicago, IL

LOCATION

Multiple Shifts

SHIFT

Job Description

As posted by the hiring company

Job Overview:

The Manufacturing Associate III (DP) is a regular full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the formulation, filtration, and aseptic filling of drug products for clinical and commercial human use. Employees employ aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning. Must comply with Kashiv BioSciences policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement.

Essential Duties & Responsibilities

To prepare and update SOPs / Protocols required for the cGMP operation.
To prepare and update training modules required for drug product manufacturing operation.
Training of Associate I and Associate II.
To take Line Inspection/Line clearance of ISO6, ISO7 and ISO8 area.
To Weigh and dispensing of materials
To operate Part washer, autoclave, filter integrity tester, and mixing system.
Operate syringe filler, glove integrity tester and non-viable particle count.
To calibrate and verify pH and conductivity meter and weighing scale.
To standardize and operate the peristaltic pump.
To perform filter integrity test.
To involve in formulation and Filtration of drug product
To involve in Aseptic filling activity with good aseptic area behavior.
Clean ISO5 and ISO6 area as per SOP.
To maintain inventory (Disinfectant solution, gowns, goggles, wipes, etc.).
To verify all raw materials and other consumables.
Responsible for equipment assembly, cleaning, sterilization, and operation.
To prepare media and buffer solutions.
Responsible for submission of samples, in-process testing, such as pH, Conductivity, personnel monitoring plates etc.
To submit documents and material requests to start batch manufacturing operations to respective departments.
To electronically record all the process steps (If required).
To complete Batch Records and other cGMP documentation accurately and in a timely manner.
To remove and dispose of soiled / expired materials from the manufacturing area.
To ensure that the manufacturing areas are maintained within the required conditions for clean room manufacturing.
Perform reconciliation of product and solutions after completion of the batch.
To report all nonconformance or events that arise during the shift to the Supervisor.
To assist in the transfer of technology from Process Development to cGMP Manufacturing.
To comply with all safety, cGMP and Company policies, practices, and procedures.
To perform other functions (Packaging) as required or assigned.
To comply with all company policies and standards.