Manufacturing Associate I (Packaging) - Rotating 1st & 2nd Shift

Amneal•Chicago, IL
•$25 - $30•Onsite

About The Position

The Drug Product Manufacturing Associate I is a regular, full-time, non-exempt position at Kashiv BioSciences, LLC in Chicago, Illinois. The role supports manufacturing biotechnology products for clinical and commercial human use, following company policies and procedures, FDA current Good Manufacturing Practices (cGMP), and other applicable government requirements. The associate performs packaging-area line inspections and clearance; operates packaging, labeling, assembly, weighing, serialization, aggregation, and sealing equipment; visually inspects products and packaging; and completes packaging, documentation, and material-handling tasks. The position involves work in GMP clean rooms and laboratories, physical movement of materials, extended standing, and accurate written documentation. The role may also perform manufacturing or visual-inspection functions as assigned. The position has rotating manufacturing shifts, with overtime, holidays, and weekends required according to process needs. The hourly pay range is $25.00–$30.00, with an opportunity for a short-term incentive such as a bonus or performance-based award within the first 12 months. Eligible employees have access to a flexible benefits program that includes health and insurance benefits and a 401(k) matching contribution.

Requirements

  • Associate college degree or higher in Biology, Chemistry, Biotechnology, Pharmacy, or a related field is preferred; alternatively, 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.
  • Excellent interpersonal skills.
  • Ability to operate complex systems and equipment in accordance with current GMPs, 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-system skills, including systems such as POMS, LIMS, SAP, or NetSuite.
  • Ability to use word processing, spreadsheets, and data-management tools.
  • Knowledge of GMP and safety requirements.
  • Ability to move around the facility to reach equipment.
  • Ability to push and pull containers; 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 occasional bending, squatting, kneeling, stooping, pushing, pulling, and reaching, as well as frequent repetitive motions.
  • Ability to produce neat and legible handwritten manufacturing documentation.

Nice To Haves

  • 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 weighing scales.
  • Associate college degree or higher in Biology, Chemistry, Biotechnology, Pharmacy, or a related field.

Responsibilities

  • Perform line inspection and line clearance in the packaging area.
  • Operate syringe labeling, label counting, blister packaging, autoinjector assembly and labeling, check-weighing, semi-automatic cartoning, serialization, aggregation, and tamper-evident sealing machines in accordance with their 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 start packaging operations.
  • Verify drug product syringes before packaging begins.
  • Electronically record process steps when required.
  • Complete logbooks, batch records, and other cGMP documentation accurately and on time.
  • Remove and dispose of soiled or expired rejected syringes and materials from the area.
  • Maintain packaging rooms and surrounding areas in the required conditions for clean-room manufacturing.
  • Report nonconformances and events arising during the shift to the Supervisor.
  • Follow safety, cGMP, company policies, practices, procedures, and standards.
  • Perform other assigned functions, including manufacturing and visual inspection.

Benefits

  • Short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.
  • Flexible benefits program for eligible positions.
  • Health and insurance benefits.
  • 401(k) matching contribution.
  • Employee well-being programs.
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