QC Particulate Lab Supervisor

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.

• 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 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.
• Perform 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.).
• Perform any other tasks/duties as assigned by management.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• 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.

• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning,…