QC Stability Assistant

Quality Seymour, Indiana


Description

Job Summary: 

This individual will support the Drug Product and Stability group, focusing on requesting and processing of stability samples, stability data, and release samples.  The position also involves assisting analytical chemists in the analysis and laboratory support for marketed products.  The individual will spend approximately 70% supporting stability and 30% for Laboratory Technician responsibilities.

 

Essential Functions:

  • Stability Support (70%):
  • Request, store and pull Stability Samples.
  • Process Stability Data and enter into Stability System software.
  • Receive and process In-process and Release samples, including DEA controlled materials.
  • Log samples and testing into Laboratory Information Management System (LIMS)
  • Update and communicate testing status to other departments.
  • Assist in maintaining stability equipment and facilities and respond to alarms during off hours.
  • Coordination of samples and testing of stability samples with the Philadelphia site and contract labs.
  • Laboratory Technical Responsibilities (30%):
  • Work with other laboratory technicians to accomplish all assigned laboratory duties as scheduled. These duties may include glassware washing, daily balance calibrations, daily pH meter calibrations, daily equipment checks, water port sanitization, monitoring HPLC waste, monitoring fume hoods, safety shower and eyewash inspections, sample/waste disposal, environmental monitoring of the facility, etc.
  • Assist Chemists in accurate and timely analysis of process verification and validation, in-process, finished product, and post-approval stability samples according to current analytical procedures, SOPs and laboratory guidelines.
  • Assist in routine setup and cleanup of equipment.
  • Assist with maintaining, receiving, stocking, and storing laboratory supplies.
  • General Functions:
  • Maintain accurate and legible notebooks and records.
  • Peer review of data and notebooks.
  • File data and reports.
  • Perform all work using appropriate safety measures.
  • Assist or manage special projects or other tasks as deemed necessary based on personal qualifications, business needs and QC management’s discretion.

 

Training or Experience:

  • Knowledge of cGMP and FDA Guidelines preferred.
  • Excellent oral and written communication skills.
  • Excellent attention to detail.
  • Working knowledge of Microsoft Word, Access and Excel. Experience with Stability System Software and Thermo LIMS preferred.
  • Demonstrated ability to work as part of a cross-functional team.
  • Strong organization and time management skills.

 

Education:

  • High School diploma (or equivalent).

 

Supervises/Manages:

  • None