QC Particulate Lab Techician
American Regent, Inc.
Shirley, NY0–3 yrs57m agovia LinkedIn
About the Role
The QC Technician will be responsible for routine testing for product release by USP and will play a supporting role in:
- Non-destructive (in vial) particle characterization
- Method development
- Routine testing for product release by USP 788 method 2 for opaque products
- Particle isolation, manipulation, and particle forensics supporting product investigations
- Process evaluation
- Examination of customer complaint CRU
- Source particle characterization and mitigation programs
- R&D container closure studies
Key Responsibilities
- Tracking/documentation of incoming samples
- Prepare particle-free water for particulate analysis
- Perform USP Method 1 and 2
- Perform Multisizer Analysis
- Perform forensic testing on unknown particulate samples
- Document all data generated from testing
- Assist with data entry for analysis and trending
- Order and track laboratory supplies
- Clean and disinfect laboratory spaces/work areas
- Assist in the characterization of particulate matter
- Perform routine testing of final dosage forms and stability samples
- Assist in the IQ/OQ/PQ of new laboratory equipment (e.g., new particulate matter systems)
- Assist in the performance of investigations
- Maintain laboratory equipment (e.g., particulate systems, sonicator, laminar flow hoods)
- Perform any other tasks/duties as assigned by management
Qualifications
- Minimum of High School Degree required
- 0-3 years in a Quality Control laboratory environment
- Aseptic processing experience preferred
- Ability to work overtime as needed
Physical Environment and Requirements
- While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.