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

The Drug Product Manufacturing Associate II 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.

Essential Duties & 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.

Qualifications

Minimum Qualifications :

Education and Experience:

• Associate college degree or higher in Biology, Chemistry, Biotechnology, Pharmacy, or related preferred
• Or an equivalent of 1 – 4 years of industry experience required.
• Operation of packaging machines (Labeling, Autoinjector, blister packing, serialization, aggregation, etc.) is preferred.

Knowledge, Skills, Abilities:

Language :

• 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.
  
  

Reasoning Skills:

• The candidate should have the 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.
  
  

Computer and/or Technical Skills:

• 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.
  
  

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:

• General Work Environment: GMP Clean rooms and Laboratories
• Standing/Lifting :

  • 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.

• Handwriting: 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.

Manufacturing shift hours:

Shift A (first shift): 06:00 AM to 2:30 PM CST,
Shift B (first shift): 9:00 AM to 5:30 PM CST (first 14 days for training),
Shift C (second shift): 2:00 PM to 10:30 PM CST,
and Shift D (third shift): 10:00 PM to 6:30 AM CST.
Overtime (time-and-a-half pay), holidays, and weekends will be required based on process requirements.

The hourly rate for this position ranges from $30.00 to $35.00 per hour. In addition, Kashiv BioSciences, LLC., offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months. Kashiv BioSciences, LLC., ranges reflect the Company’s good faith estimate of what Kashiv BioSciences, LLC., reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.