American Regent
Pharmaceutical
QCParticulateLabSupervisor
Neural analysis suggests this role is
optimal for Mid candidates.
“QC Particulate Lab Supervisor at American Regent. Skills: QC Particulate Lab Supervision, Method Development, Routine Testing. 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; Product investigations; Process evaluation; Customer complaint investigation; Source particle characterization and mitigation programs
Physically able to wear laboratory protective gowning and equipment, Gowning, Goggles, Face shields, Respirators, 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, background in analytical instruments, 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
What You'll Do.
Supervise QC Particle Lab Scientists
Allocate resources for routine testing
Lead continuous improvement of lab procedures
Perform destructive particle characterization
Perform routine testing for product release
Isolate and manipulate particles
Support product investigations
Examine customer complaints
Characterize source particles
Develop mitigation programs
Support R&D container closure studies
Supervise Standards workstream
Delegate work assignments
Perform reviews of reports
Train laboratory analysts
Assist analysts with particulate analysis
Review vendor calibration reports
Perform microscopic particle count test
Perform light obscuration tests
Assist with particulate matter characterization
Review USP method 2 test results
Ensure proper documentation
Maintain training records
Write and perform validation studies
Maintain service contracts
Order and track laboratory materials
Stay current with safety audit expectations
Assist with IQ/OQ/PQ of new equipment
Interface with American Regent departments
Perform investigational particulate analysis
Perform special investigative studies
Participate in audits
Attend industry courses/meetings
Read pharmaceutical industry literature
Perform other tasks as assigned
How You'll Work.
Team & Collaboration
Interface effectively with all applicable American Regent departments; Collaborate with product team
Communication Scope
oral and written communication skills
Process & Methodology
Coordinate workload of others, Monitor progress through completion
Full Job Description
**Nature and Scope** The QC Particulate Lab Supervisor will be responsible for the supervision of the QC Particle Lab Scientists and will assure the appropriate allocation of resources to complete routine testing for product release by USP Method 2 – Microscopic Method, USP Multisizer 4e, Reject Characterization reports and forensic analysis reports. The QC Particulate Lab Supervisor will take on a leadership role in the continuous improvement of lab procedures and techniques, and will play a significant role in destructive 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, and R&D container closure studies and will supervise the Standards workstream. **Essential Duties and Responsibilities** Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. * Delegate work assignments and monitor progress through completion. * Perform reviews of reports. * Train and assist laboratory analysts in the performance of particulate analysis (PLM and microscopic test methodologies). * Review results & reports generated from outside vendor calibration/recalibration of particulate analysis equipment. * Perform the microscopic particle count test, light obscuration tests and other implemented technologies. * Assist with the characterization of particulate matter. * Review USP method 2 – Microscopic Method (Particulate Matter in Injections) routine test results for final dosage forms and stability samples. * Ensure the proper documentation of laboratory data. * Maintain training records. * Write SOPs (e.g., microscopic analysis and characterization of particulate matter). * Write and perform validation studies/reports. * Maintain se
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