Job Details
Job Type
Full-time
Description
The Manufacturing Associate I, 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
- Performs Line Inspection/Line Clearance of Packaging area.
- Operates syringe or Vial labeling, label counting, blister packaging, check weigher, serialization, aggregation, and temper evident sealing Machines by following SOP.
- Visually inspects labeled syringes, blister packs, printed cartons, or shippers for any defects.
- Responsible for submission of samples.
- Packs syringes with other necessary components manually in cartons.
- Checks weight of cartons to ensure no missing components.
- Packs good cartons into shipper and performs palletization.
- Submits documents and material request to start packaging operation to respective department.
- Verifies all drug product syringes before starting any packaging activity.
- Electronically records all the process steps (If required).
- Completes logbooks, Batch Records, and other cGMP documentation accurately and in a timely manner.
- Removes and disposes soiled / expired, rejected syringes, materials from the area.
- Ensures that the packaging rooms and surrounding areas are maintained within the required conditions for clean room manufacturing.
- Reports all nonconformance or events that arise during the shift to the Supervisor.
- Complies with all safety, cGMP and Company policies, practices, and procedures.
- Performs other functions (Manufacturing, Visual inspection) as required or assigned.
- Complies with all company policies and standards.
Requirements
Education: - High School Diploma or GED preferred
- 1 - 2 years of packaging experience in Pharma/BioPharma.
Special Skills 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.
Work Environment & Physical Demands: General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. Some travel may be involved.
Supervisory Responsibility, if any : No
Benefits/Perks: - Medical (FSA/HSA)
- Dental
- Vision
- 401K
- Commuter/Transit Benefits
- Student Loan Assistance
- 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
This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization. Kashiv Biosciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Kashiv Biosciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.