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.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Demonstrate competency on assigned qualification blocks:
- Job specific Standard Operating Procedures
- Candidates for Inspector Qualification will require New Inspector Qualification and New Label Inspection Certification.
- Candidates for Final and Bulk Packaging will require New Label Inspection Certification.
- All candidates will execute and document procedural steps in compliance with cGMP standards.
- All candidates will review all documentation generated as each step is completed for accuracy of calculations / data entry and completeness of process signature steps and inform the appropriate leader of out of specification results.
- All candidates will 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 locations.
- All candidate will understand the operation and safety requirements for the use of manual pallet jack, electric pallet jack, hydraulic lift gate, and any additional equipment used for transporting materials.
- All candidates will perform room clearances in accordance with relevant Standard Operating Procedures
- Candidates for Certified Visual Inspection must perform 100% visual inspection of product and classify rejected materials utilizing approved categories within required timelines (Qualification)
- Candidates for Final and Bulk Packaging must perform 100% visual inspection of inkjetted lot numbers, labels with lot number and expiration date and classify rejected materials utilizing the approved categories within required timelines.
- Candidates for Final and Bulk Packaging must manually package product in final packaging components while verifying that lot information, including lot number and expiration date, are accurate
- Candidates for Final and Bulk Packaging must load and unload product from vial labeling machine during labeling process
- Candidates for Final and Bulk Packaging must package product in final packaging components while verifying that lot information, including lot number and expiration date, are accurate
- All candidates will 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
- All candidates will stock gowning and consumable supplies in the controlled areas maintaining Just-In-Time inventory (JIT) control of manufacturing materials
- All candidates must pass a 20/20 near sighted vision screening and the color blindness test.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
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.
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.