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Assistant Tech, Label

4 months ago

Baltimore, Maryland, United States Emergent BioSolutions Full time

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:
Job specific Standard Operating Procedures
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 re-qualification 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-In-Time inventory (JIT) control of manufacturing materials

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: Education, Experience & Skills

• HS Diploma or equivalent

• 0-2 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.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.