Assistant Tech, Label - Baltimore, United States - Emergent Biosolutions
Description
We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world.
Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
I:
Job Summary
This position is responsible for the inspection and packaging of product. Will perform all aspects of Inspection and Packaging with the ability to assist in day to day operations.
II:
Responsibilities
- Demonstrate competency on assigned qualification blocks:
New Inspector Qualification
- Execute and document procedural steps in compliance with cGMP standards.
- Adhere to the procedures and safe practices for movement of product and materials and accurately complete all applicable documentation. This applies to room temperature and cold storage loctions.
- Perform room clearances in accordance with relevant Standard Operating Procedures
- Perform 100% visual inspection of product and classify rejected materials utilizing approved categories within required timelines (Qualification)
- Successfully complete annual inspector requalification requirements
- Manually package product in final packaging components while verifying that lot information, including lot number and expiration date, are accurate
- Load and unload product from vial labeling machine during labeling process
- Package product in final packaging components while verifying that lot information, including lot number and expiration date, are accurate
- Maintain state of facility environmental control including: preparation of defined concentrations of cleaning solutions, daily, monthly, quarterly and annual cleaning of manufacturing surfaces and equipment per Standard Operating Procedures
- Review all documentation generated as each step is completed for accuracy of calculations / data entry and completeness of process signature steps
- Stock gowning and consumable supplies in the controlled areas maintaining Just-InTime inventory (JIT) control of manufacturing materials
III:
Education, Experience & Skills
- HS Diploma or equivalent
- 02 years of relevant experience
- Knowledge of cGMP and CFR requirements
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees.
This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.More jobs from Emergent Biosolutions
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