Manufacturing Associate II (Packaging) - Rotating 1st & 2nd shift

Amneal•Chicago, IL

4h•$30 - $35•Onsite

About The Position

The Drug Product Manufacturing Associate II is a regular, full-time, non-exempt employee at Kashiv BioSciences, LLC, in Chicago, Illinois. The role is responsible for manufacturing biotechnology products for clinical and commercial human use while complying with company policies and procedures, FDA current Good Manufacturing Practices (cGMP), and other government requirements. The associate performs packaging-area line inspections and clearances; operates packaging, labeling, assembly, weighing, serialization, aggregation, and sealing equipment; and visually inspects products and packaging for defects. The role also includes preparing and packing products, checking carton weights and packaging components, palletizing shippers, submitting samples and documentation, and recording process steps. The associate completes batch records and logbooks, removes rejected or expired materials, maintains clean-room conditions, reports nonconformances to the Supervisor, and follows safety, cGMP, and company requirements. Work is performed in GMP clean rooms and laboratories. The role requires standing for extended periods, moving throughout the facility, lifting and moving containers, frequent repetitive motions, and occasional bending, squatting, kneeling, stooping, pushing, pulling, and reaching. Overtime, holidays, and weekends are required based on process needs. The hourly pay range is $30.00–$35.00, with an opportunity for a short-term incentive such as a bonus or performance-based award within the first 12 months.

Requirements

Associate college degree or higher in Biology, Chemistry, Biotechnology, Pharmacy, or a related field, or equivalent industry experience of 1–4 years.
Basic verbal and written English communication skills, including the ability to understand technical information, procedures, batch records, and other documents.
Excellent interpersonal skills.
Ability to operate complex systems and equipment according to current GMPs, SOPs, and safety guidelines with minimal supervision.
Basic ability to identify problems and troubleshoot equipment and manufacturing processes.
Ability to work independently within SOPs and prescribed guidelines or as a team member, and to follow detailed directions.
Computer skills involving systems such as POMS, LIMS, SAP, or NetSuite.
Ability to use word-processing, spreadsheet, and data-management applications.
Knowledge of GMP and safety requirements.
Ability to lift at least 25 pounds; frequently move 25–50 pounds on carts; and frequently move 100–250 pounds with assistance.
Ability to stand for long periods and perform frequent repetitive motions, with occasional bending, squatting, kneeling, stooping, pushing, pulling, and reaching.
Ability to produce neat, legible manufacturing documentation.
Availability for overtime, holidays, and weekends based on process requirements.

Nice To Haves

An associate college degree or higher in Biology, Chemistry, Biotechnology, Pharmacy, or a related field.
Experience operating packaging machines such as labeling, autoinjector, blister-packing, serialization, and aggregation equipment.
Knowledge of biotechnology operations and equipment, including aseptic filtration systems, aseptic sampling, filter integrity testing, stirrer plates, floor scales, peristaltic pumps, and weigh scales.

Responsibilities

Perform line inspections and line clearance in the packaging area.
Operate syringe labeling, label counting, blister packaging, autoinjector assembly and labeling, check-weighing, semi-automatic cartonating, serialization, aggregation, and tamper-evident sealing equipment according to applicable SOPs.
Visually inspect labeled syringes and autoinjector devices, blister packs, printed cartons, and shippers for defects.
Submit samples.
Participate in investigations when needed.
Manually pack syringes and necessary components into cartons.
Check carton weights to ensure components are not missing.
Pack acceptable cartons into shippers and palletize them.
Submit documents and material requests to the appropriate department to begin packaging operations.
Verify drug product syringes before packaging begins.
Electronically record process steps when required.
Accurately and promptly complete logbooks, batch records, and other cGMP documentation.
Remove and dispose of soiled, expired, or rejected syringes and materials from the area.
Maintain packaging rooms and surrounding areas in the conditions required for clean-room manufacturing.
Report nonconformances and events arising during the shift to the Supervisor.
Comply with safety, cGMP, company policies, practices, and procedures.
Perform other assigned functions, including manufacturing and visual inspection.