Quality Technician

Location: St. Louis, MO Pay Rate: $36.00 - $40.00/hr Duration: 8 months Hours: M-F 9-5 (these hours can be varied) , No OT expected Summary: Stability performs essential duties in ensuring the Stability Program operates effectively and in compliance with US and International pharmaceutical manufacturing regulations/guidance documents. The scope of responsibility includes packaging, storage and delivery of stability material in a timely manner to avoid undue burden on the testing laboratories, updating department Work Instructions or site Quality System Procedures and developing solutions to routine technical problems of limited scope to improve department efficiencies. ESSENTIAL FUNCTIONS: •Manages and maintains stability samples under ICH, FDA, DEA and cGMP regulations •Pulls and delivers stability samples at testing intervals •Package stability samples per study requirements •Maintains controlled substance inventory in compliance with applicable DEA regulations •Works with LIMS team to ensure stability module of LIMS system is maintained and functional •Ensures stability studies are entered into LIMS accurately and timely •Responsible for packaging, labeling, and storage of stability samples •Shares responsibility for Stability Packaging functions and sample pulls as needed. Qualifications: Excellent communication skills. Ability to work in and promote a team environment. Understanding and application of principles, concepts, practices, and standards within discipline. Knowledge of stability chambers and laboratory equipment. Ability to read and interpret graphs. Ability to lead and influence people. Understanding of basic statistical principles. Dealing with Ambiguity, Approachability, Decision Quality, Functional/Technical Skills, and Integrity and Trust. Customer Focused Other Skills: Knowledge of ELN, LIMS, Excel, MiniTab. REQUIREMENTS: Education: Some technical, community college or college credits. Experience: Minimum of 1-year related experience in Quality programs. Some knowledge of pharmaceutical regulations including current GXP, GLP, or GMP requirements. Benefits (employee contribution): Health insurance Health savings account Dental insurance Vision insurance Flexible spending accounts Life insurance Retirement plan ll qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. #IND11