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

Amneal•Chicago, IL

18d•Onsite

About The Position

The Drug Product Manufacturing Associate II is a regular, full-time, non-exempt position at Kashiv BioSciences, LLC, in Chicago, Illinois. The employee manufactures 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 role performs packaging-line inspections and line clearance; operates packaging, labeling, assembly, weighing, serialization, aggregation, and sealing equipment; visually inspects products and packaging; and packs products and components into cartons and shippers. The employee also verifies materials and drug product syringes, submits samples and requests, completes required electronic records and cGMP documentation, removes rejected or expired materials, maintains clean-room conditions, reports nonconformances, and participates in investigations as needed. Work takes place in GMP clean rooms and laboratories. Shift schedules listed include first, second, and third shifts; overtime, holidays, and weekends may be 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

An associate college degree or higher in Biology, Chemistry, Biotechnology, Pharmacy, or a related field is preferred, or an equivalent of 1–4 years of industry experience is required.
Basic verbal and written English communication skills, including the ability to understand technical information, procedures, batch records, and other documents.
Ability to operate complex systems and equipment in accordance with cGMP, SOPs, and safety guidelines under minimum 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 for working with systems such as POMS, LIMS, SAP, and NetSuite, and with word processing, spreadsheets, and data management.
Knowledge of GMP and safety requirements.
Ability to produce neat and legible manufacturing documentation in accordance with Good Manufacturing and Good Documentation Practices.
Ability to move around the facility, stand for long periods, and perform frequent repetitive motions.
Ability to lift at least 25 pounds; frequently move 25–50 pounds on carts; and frequently move 100–250 pounds with assistance.
Ability to perform occasional bending, squatting, kneeling, stooping, pushing, pulling, and reaching.

Nice To Haves

Experience operating packaging machines, including labeling, autoinjector, blister-packing, serialization, and aggregation equipment.
Knowledge of biotechnology operations and equipment such as aseptic filtration systems, aseptic sampling, filter integrity testing, stirrer plates, floor scales, peristaltic pumps, and weighing scales.
Excellent interpersonal skills.

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 in accordance with applicable SOPs.
Visually inspect labeled syringes, labeled autoinjector devices, blister packs, printed cartons, and shippers for defects.
Submit samples and participate in investigations as 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 documentation and material requests to the appropriate department to start packaging operations.
Verify drug product syringes before packaging activities begin.
Electronically record process steps when required.
Complete logbooks, batch records, and other cGMP documentation accurately and promptly.
Remove and dispose of soiled, expired, or rejected syringes and materials.
Maintain packaging rooms and surrounding areas within required clean-room conditions.
Report shift-related nonconformances and events to the supervisor.
Follow safety, cGMP, and company policies, practices, procedures, and standards.
Perform other assigned functions, including manufacturing and visual inspection.