Examine bulk batches coming from Compounding
Provide instructions to Compounding to remediate batches out of specification
Release or reject batches, depending on laboratory results
Maintain a safe working environment and follow safety guidelines & GMPs
Provide technical, customer relations, and personnel management for major programs and projects
Test bulk batches vs. standards and specifications
Adjust batches within specification if required
Replace stability samples in stability-chamber at appropriate temperatures
Test stability samples according to schedules and report problems/failures to R&D Manager
Calibrate laboratory instruments daily
Test line start-up samples as soon as possible
Keep notebooks up-to-date and signed according to GMP regulations
Review raw material test data and release materials in the warehouse management system
Send out bulk micro samples for testing if needed
Create Certificates of Analysis for bulk products
Test samples from external contract manufacturers
Prepare chemical solutions as needed
Change stability-chamber charts monthly
Change status of finished goods in the Warehouse Management System as needed

Bachelor Degree in related science field
1-year experience in a related manufacturing position
Excellent communication (verbal and written) and organizational skills
Detail-oriented
Ability to read and interpret technical procedures and specifications
Ability to effectively present information and respond to questions from management and inter-department staff
Capable of working with peers and associates from other departments in a proactive and constructive manner
Ability to successfully engage and lead individual and team discussions and meetings
Ability to add, subtract, multiply & divide into all units of measure, using whole numbers, common fractions, and decimals
Ability to work with little supervision and use independent discretion
Ability to operate computerized lab equipment and maintain accurate data/records
Strong analytical and problem-solving abilities
Team-oriented and able to successfully work independently or in a collaborative/group setting
Flexible, adaptable, and capable of working in a fast-paced environment
Ability to apply all relevant policies in a consistent, timely and objective manner
Ability to handle multiple tasks and shift priorities as necessary
Uses time effectively
Gathers and analyzes information skillfully
Proficient use of MS Office (Word, Excel and Outlook)

QA Laboratory Technician, Level 1

Key skills