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- 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.
- High School Diploma or GED preferred
- 1 – 2 years of packaging experience in Pharma/BioPharma.
- 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.
- 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.
- 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
Packaging Associate - Chicago, United States - Unicon Pharma Inc
Description
Job Description
Job DescriptionShift:
1st Shift 6am – 2:30pm
2nd Shift 2:00pm – 10:30pm
Description
This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. Must comply with Client policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirements.
Essential Duties & Responsibilities
Requirements
Education:
Special Skills
Language:
Reasoning Skills:
Computer and/or Technical Skills:
From our inception, we've maintained a singular focus on working with Life Science companies and the industry's leading businesses. We leverage our experienced, customer-facing team, vast network of 90,000+ Life Sciences professionals, and relationship-first approach to become your trusted advisor and empower you to achieve your goals and future jobs. We'll work closely with you to listen to your needs, consult you on the most strategic solution, and partner with you to deliver that solution. So, contact us today, stop settling for subpar talent and instead partner with the industry experts and focus more on what you do best: growing your career in an effort to improve quality of life for communities around the world.
Company Description
We focus exclusively on Life Sciences—Nothing Else.\r\r
From our inception, we've maintained a singular focus on working with Life Science companies and the industry's leading businesses. We leverage our experienced, customer-facing team, vast network of 90,000+ Life Sciences professionals, and relationship-first approach to become your trusted advisor and empower you to achieve your goals and future jobs. We'll work closely with you to listen to your needs, consult you on the most strategic solution, and partner with you to deliver that solution. So, contact us today, stop settling for subpar talent and instead partner with the industry experts and focus more on what you do best: growing your career in an effort to improve quality of life for communities around the world.