American Regent
pharmaceutical
QCParticulateLabSupervisor
“QC Particulate Lab Supervisor at American Regent. Skills: Supervision, Particulate Analysis, Method Development. Supervise QC Particle Lab Scientists. Allocate resources for routine testing”
What You'll Achieve.
assure the appropriate allocation of resources to complete routine testing for product release
Industry & Context.
forensic analysis reports; particle forensics supporting product investigations; investigations of OOS; OOT
Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.
What They're Looking For.
Must Have
BS Degree in Chemistry or related science with a minimum of five (5) years pharmaceutical experience required, Minimum of 1 year experience supervising and/or coordinating the workload of others including coaching and being the go-to person for expert knowledge and advice, understanding of Good Laboratory Practices (GLP) including Good Documentation Practices (GDP) and laboratory safety, oral and written communication skills, organizational and time management skills, Knowledge of Microsoft Office including Word and Excel
Nice to Have
MS Degree in Chemistry or related science with three (3) years pharmaceutical experience preferred, PhD Degree in Chemistry or related science with one (1) year pharmaceutical experience a plus, Aseptic processing experience preferred, background in analytical instruments
What You'll Do.
Supervise QC Particle Lab Scientists
Allocate resources for routine testing
Lead continuous improvement of lab procedures
Perform destructive particle characterization
Develop methods for routine testing
Perform particle isolation and manipulation
Support product investigations with particle forensics
Support process evaluation
Support examination of customer complaints
Support source particle characterization
Support mitigation programs
Support R&D container closure studies
Supervise Standards workstream
Delegate work assignments and monitor progress
Perform reviews of reports
Train laboratory analysts in particulate analysis
Review results from outside vendor calibration
Perform microscopic particle count test
Perform light obscuration tests
Assist with characterization of particulate matter
Review USP method 2 test results
Ensure proper documentation of laboratory data
Maintain training records
Write and perform validation studies/reports
Maintain service contracts with outside vendors
Ensure ordering and tracking of laboratory materials
Stay current with safety audit inspection expectations
Assist with IQ/OQ/PQ of new laboratory equipment
Interface effectively with American Regent departments
Perform investigational particulate analysis
Perform special investigative and support studies
Participate in internal and external audits
Attend industry courses/meetings
Read and stay current with pharmaceutical industry literature
Perform any other tasks/duties as assigned
How You'll Work.
Team & Collaboration
Interface effectively with all applicable American Regent departments; Participate in internal and external audits
Communication Scope
oral and written communication skills
Process & Methodology
resource planning, time management skills
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