QC Stability Supervisor

GSK•King of Prussia, PA

20h

About The Position

The Quality Control Stability supervisor is responsible for the oversight and logistical requirements for samples associated with both internal and external assets. The role will oversee stability and sample coordinators and the activities involved with receiving and preparing quality control samples for further processing, providing inputs to procedures and stability protocols, shipping or releasing samples to the designated testing labs and ensuring metrics are analyzed and reviewed. In addition, the supervisor supports their team with equipment management and lab duties, mentors their team, supports product regulatory submissions and inspections, oversees laboratory activities for the team, oversees and/or assists with problem solving, works closely with supervisors and project leads from other teams within and outside of QC to ensure areas of handover occur without issues, and supports contract lab oversight for samples shipped externally. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Oversees a variety of sample management activities (receipt, storage, aliquotting, shipping, discard, destruction, etc.). Actively mentors and assesses the needs of the stability team. Manages team’s training documents, assessments, work orders, and records. Assigns work orders and other team tasks, reviews work orders, and ensures on-time completion Authors, reviews, and approves procedures, protocols and reports. Oversees stability study set downs, moves and pulls based on stability and release testing schedules and provides inputs into the schedule. Monitors and assists with any compliance issues related to stability and/or sample management, including but not limited to Deviations/Investigations, Out of Specification, Quality Audit and Inspections, Change Controls and Training. Ensures team is maintaining controlled temperature units (CTUs) and associated rooms including the work processes associated with the use and maintenance of the controlled temperature units. Oversees team’s response to environmental unit alarms and participate in on-call responsibilities. Keep the stability infrastructure in an audit ready state including ensuring local procedures are current with global policies and industry expectations as well as aligned with GSK’s policies on regulatory expectations. Performs daily GEMBAs to ensure team is in compliance and that issues are quickly discovered and resolved using global problem solving tools.

Requirements

Bachelor's degree Chemistry, Biochemistry, Stability, Sample Management, Sample Logistics, or science related field
5 years experience in a GxP regulated laboratory environment

Nice To Haves

Biopharmaceutical experience is preferred with an awareness of various biopharmaceutical techniques and assays
System experience preferred – SAP/ERP, LES, InfoLogs, MS Excel, Word, Powerpoint
Advanced knowledge of cGXP, ICH guidelines, FDA, USP/EP/JP and data integrity guidelines and regulations
Strong team player with demonstrated ability to lead and motivate a diverse team.
Strong organizational and task management skills.
Strong understanding of stability and/or sample management/logistics.
Strong trending, technical writing, and communication (verbal and written) skills.
Demonstrated ability to solve complex technical problems using GPS/six sigma

Responsibilities

Oversees a variety of sample management activities (receipt, storage, aliquotting, shipping, discard, destruction, etc.).
Actively mentors and assesses the needs of the stability team.
Manages team’s training documents, assessments, work orders, and records.
Assigns work orders and other team tasks, reviews work orders, and ensures on-time completion
Authors, reviews, and approves procedures, protocols and reports.
Oversees stability study set downs, moves and pulls based on stability and release testing schedules and provides inputs into the schedule.
Monitors and assists with any compliance issues related to stability and/or sample management, including but not limited to Deviations/Investigations, Out of Specification, Quality Audit and Inspections, Change Controls and Training.
Ensures team is maintaining controlled temperature units (CTUs) and associated rooms including the work processes associated with the use and maintenance of the controlled temperature units.
Oversees team’s response to environmental unit alarms and participate in on-call responsibilities.
Keep the stability infrastructure in an audit ready state including ensuring local procedures are current with global policies and industry expectations as well as aligned with GSK’s policies on regulatory expectations.
Performs daily GEMBAs to ensure team is in compliance and that issues are quickly discovered and resolved using global problem solving tools.