QC Particulate Lab Supervisor

About the role

The QC Particulate Lab Supervisor will oversee the QC Particle Lab Scientists and ensure the timely completion of routine testing for product release by USP Method 2 – Microscopic Method, USP Multisizer 4e, Reject Characterization reports, and forensic analysis reports. This role involves leading continuous improvement efforts in lab procedures and techniques, and playing a key 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 evaluations, customer complaint reviews, source particle characterization, and mitigation programs, as well as supervising the Standards workstream.

Responsibilities

• 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.
• Afford assistance with the characterization of particulate matter.
• Ensure 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 service contracts with outside vendors.
• Ensure the ordering and tracking of laboratory materials.
• Stay current with safety audit inspection expectations.
• Assist with the IQ/OQ/PQ of new laboratory equipment (e.g., new particulate matter systems).
• Interface effectively with all applicable American Regent departments.
• Assist with investigational particulate analysis and documentation for customer complaints.
• Perform special investigative and support studies.
• Supervise the Standards workstream.
• Participate in internal and external audits (e.g., product specific, GMP, FDA, etc.).
• Attend in-house and/or current industry courses/meetings to attain current knowledge and experience with USP testing and pharmaceutical science.
• Read and stay current with pharmaceutical industry literature as it applies to laboratory operations (i.e., PDA, ASM, local chapters, scientific journals, the setting of alert/action levels, investigations of OOS, OOT, etc.).

Qualifications

• BS Degree in Chemistry or related science with a minimum of five (5) years pharmaceutical experience required or MS Degree in Chemistry or related science with three (3) years pharmaceutical experience preferred or PhD Degree in Chemistry or related science with one (1) year pharmaceutical experience a plus.
• 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.
• Strong understanding of Good Laboratory Practices (GLP) including Good Documentation Practices (GDP) and laboratory safety.
• Aseptic processing experience preferred.
• Strong background in analytical instruments.
• Strong oral and written communication skills.
• Strong organizational and time management skills.
• Knowledge of Microsoft Office including Word and Excel.