Job Description :
Pay Range $17hr - $21hr
Skill Requirements :
- 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).
- 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.
- Adheres to safety standards, identifies unsafe situation / habit and escalates appropriately.
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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