Assistant Tech, Label & Packaging
Emergent BioSolutions
- Baltimore, MD
- Permanent
- Full-time
- Demonstrate competency on assigned qualification blocks:
o 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
- HS Diploma or equivalent
- 0-2 years of relevant experience
- Knowledge of cGMP and CFR requirements
- Lead with Integrity
- We gain trust and confidence through ethics, quality, and compliance excellence
- Stand shoulder to shoulder no matter what
- We combine our best thinking and communicate openly to support each other.
- Own it always
- Every person at Emergent is engaged and accountable for delivering on our commitments.
- Break through thinking
- We take smart risks, pursue innovation and challenge ourselves to constantly improve.
- Compete where it counts
- We set the right goals and respect each other as we conquer them together.