Career Category

Job Description

Job Summary:

Under minimal supervision, the Sr. Associate Quality Control staff member will be responsible for activities including sample and stability data management, assistance with reviewing and authorizing documents and samples, and supporting incoming and outbound shipments of samples as part of a highly dynamic team.

Perform sample management, sample handling, for all sample types including but not limited to stability, in-process, and raw materials to support GMP operations across ARI. Oversee sample management within the SM-LIMS systems and also support data entry and review within that system. Generate complete, accurate, and concise laboratory documentation using electronic systems, such as LIMS, CIMS, and other laboratory systems as needed. Operate and maintain specialized laboratory equipment and instrumentation. Participate in QC laboratory investigations and audits as necessary. Perform general laboratory housekeeping activities Maintain training compliance and proficiency At all times, comply with safety guidelines, cGMPs and other applicable regulatory requirements.

Basic Qualifications:

Master’s degree 
OR
Bachelor’s degree and 2 years of Quality Control Laboratory experience
OR 
Associate’s degree and 6 years of Quality Control Laboratory experience
OR  
High school diploma / GED and 8 years of Quality Control Laboratory experience

Preferred Qualifications:

Professional work experience in a fast-paced, flexible GMP laboratory. Leadership ability, to assist with the daily/weekly schedule, routine shipping and sample management questions and issues, and system/sample troubleshooting. Ability to generate and revise SOPs . Demonstrated proficiency with electronic systems (LIMS, LMES, CIMS, Trackwise, etc.). Ability to generate, update, and close deviations and analytical result assessments in Trackwise. Ability to manage and lead Operational Excellence initiatives including 5S, and Standard Work. Demonstrated written and oral communication skills, project management and presentation skills, and proven ability to manage priorities effectively. Demonstrated ability to be flexible and adaptable to support business needs.