Job Description

1st Shift: Mon-Fri, 6:00AM-2:30PM

Executes routine unit operations in Manufacturing Assembly and Packaging as assigned related to the manufacturing of drug product in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures.

This position is responsible for assisting the Sr. Associate and Master Associate in performing assembly and packaging in designated functional manufacturing area. Support with troubleshooting to equipment.

Duties & Responsibilities:

• Assists in the setup of the automated autoinjector assembly machine, pre-filled syringe assembly machine and semi-automated tabletop machine. This assistance includes tasks such as gathering tools, machine parts and documents required for such activities. Retrieves components and equipment from storage
• Assists with the equipment changeover
• Assists with minor equipment repairs/adjustments
• Assists with real-time identification and correction of problems. Problems may include, but are not limited to mechanical issues, component issues
• Performs all work in accordance with Company Policies and Procedures. All work is documented in controlled documents (batch records, logbooks or SOP attachments) in accordance with SOP. All activities are to be documented in the batch record. All events are to be recorded in the batch record and brought to the attention of the production supervisor for further action.
• Assists with room cleaning in production areas. Will transfer rubbish to the transfer zones and may empty transfer zones of rubbish when required. This includes removal of equipment, room sanitization and disposal of waste according to established safety requirements
• Responsible for following controlled documents to ensure that the equipment identified for operations are used and documented. This includes verification of equipment calibration. Completes logbooks, as required.
• Responsible for performing assembly and packaging operations and assisting in visual inspection/filling operations, if required.
• Ensures components, materials and supplies are stocked prior to the start of the assembly and packaging operations
• Movement of product and components within the assembly and packaging area
• Transfer product, components and equipment within the CNC area.
• Communication and hand-off to relief personnel during shift change as appropriate
• Maintains production areas according to predefined standards (5s)
• Adheres to safety standards, identifies unsafe situation / habit and escalates appropriately

Skills

Skill Requirements:

• Basic reading, writing and understanding of English
• Read and follow Standard Operating Procedures (SOP)
• Basic math calculations (addition, subtraction, multiplication, division)
• Perform documentation according to Good Documentation Practices (GDP)
• Basic computer skills - write & send e-mail communications, utilize Microsoft office programs (Outlook, Internet Explore/Edge)

Education Requirements:

• High School degree plus minimum one (1) year work experience in GMP regulated industry
• Associate/Bachelor degree from an accredited institution or biotechnology vocational training preferred

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