III (DP) - Packaging

Kashiv Biosciences•Chicago, IL

3d•Onsite

About The Position

The Drug Product Manufacturing Associate I / II / III is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. Must comply with Kashiv BioSciences policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirements.

Requirements

Associate college degree or higher in Biology, Chemistry, Biotechnology, Pharmacy, or related preferred Or an equivalent of 1 – 4 years (for Associate I and II) and 4 – 6 years (for Associate III) of industry experience required.
Operation of packaging machines (Labeling, Autoinjector, blister packing, serialization, aggregation, etc.) is preferred.
Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English.
Excellent interpersonal skills.
Ability to operate complex systems and equipment in accordance with current GMPs, SOPs, and safety guidelines under minimum supervision.
Basic skills for identifying problems and troubleshooting of the equipment and manufacturing processes.
Ability to work independently, within SOP, prescribed guidelines, or as a team member and the demonstrated ability to follow detailed directions.
Skills for working with Computer systems, such as: POMS, LIMS, SAP, NetSuite etc.
Operation and understanding of word processing, spreadsheets, and data management.
Knowledge of GMP and safety requirements.
Knowledge of biotechnology operations such as, Aseptic Filtration Systems, Aseptic Sampling, Filter Integrity Testing, stirrer plate, floor scale, peristaltic pump, Weigh Scales, etc.
Must be able to move around the facility to reach various equipment
Physical lifting and shift required for pushing and pulling containers
Must be able to lift at least 25 lbs. Frequent moving of 25-50 lbs. on carts.
Frequent moving of 100-250 lbs. with assistance.
Must be able to stand for long periods of time
Occasional bending, squatting, kneeling, stooping, pushing, pulling, reaching.
Frequent repetitive motions.
Manufacturing processes require extensive documentation in accordance with current Good Manufacturing and Good Documentation Practices. Such documentation must be product in a manner that is both neat and legible.
High-paced demanding environment to meet ambitious project goals.
Limited to no travel

Nice To Haves

Associate college degree or higher in Biology, Chemistry, Biotechnology, Pharmacy, or related preferred
Operation of packaging machines (Labeling, Autoinjector, blister packing, serialization, aggregation, etc.) is preferred.

Responsibilities

To take Line Inspection/Line clearance of the Packaging area.
To operate the syringe labeling machine, label counting, blister packaging, Autoinjector Assembly and labeling machine, check weigher, Semi-Automatic cartonator machine, serialization, aggregation, and tamper-evident sealing Machines by following respective SOP.
To visually inspect labeled syringes, labeled autoinjector devices, blister packs, printed cartons, or shippers for any defects.
Responsible for submission of samples.
To participate in investigations if needed.
To pack syringes with other necessary components manually in cartons.
To check the weight of cartons to ensure there are no missing components.
To pack good cartons into the shipper and do palletization.
To submit documents and material requests to start packaging operations to the respective department.
To verify all drug product syringes before starting packaging activity.
To electronically record all the process steps (If required).
To complete logbooks, Batch Records, and other cGMP documentation accurately and in a timely manner.
To remove and dispose of soiled / expired, rejected syringes and materials from the area.
To ensure that the packaging rooms and surrounding areas are maintained within the required conditions for clean room manufacturing.
To report all nonconformance or events that arise during the shift to the Supervisor.
To comply with all safety, cGMP and Company policies, practices, and procedures.
To perform other functions (Manufacturing, Visual inspection) as required or assigned.
To comply with all company policies and standards.

Benefits

Medical Insurance - Aetna Prescription Drug Converge | Rx Virtual Visits - Aetna/Teladoc
Health Savings Accounts (HSA)
Flexible Spending Accounts (FSA)
Dental Insurance - Aetna
Vision Insurance - VSP
Life and AD&D Insurance
Disability Benefits
Supplemental Benefits
Legal Services
ID Theft Protection
Travel Assistance
Value Added Benefits & Services
Health Advocate
Life Assistance Program (LAP)
Student Loan Assistance Program
401K
Monthly Cell Phone Allowance
Free Parking (Company Paid)
Conveniently located next to the Metra, Green and Red Line
One block east of the Chicago White Sox Stadium
Less 10 minutes away from Downtown Chicago