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Stefanini Group is hiring for a Quality Control Analyst I. Exciting opportunity awaits! Let us help you get started. Call Aditya Yadav - 248 728 6487 or email me at Aditya.Yadav@ stefanini.com Summary: Conduct specific biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods, and may include environmental monitoring programs. Essential Duties and Responsibilities: Conduct critical biological, chemical and physical analyses such as raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at manufacturing facilities, etc.Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS system). Perform assays requiring precise analytical skills and understanding of biology and chemistry principles. Complete all testing, including special project / protocol testing in a timely and appropriate manner.Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.Write exception documents.Participate in functional efforts involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality. Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.May perform equipment maintenance and calibrations as required. May perform other duties as assigned.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.Ability to handle multiple tasks concurrently, and in a timely fashion.Computer literate. Must be detail oriented, conscientious and have high reading comprehension skills. Must have basic understanding of laboratory instrumentation.Must be able to communicate effectively with supervisors and peers. Must be able to read, write, and converse in English. Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training, performance management, and self service applications.Must have the ability to navigate electronic mail systems and intranet for communication purposes.Good interpersonal skills and be able to work effectively and efficiently in a team environment.Knowledge of cGMP manufacturing. Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment, and CIP/SIP systems. Knowledge of basic chemical and biological safety procedures. Must be able to read and follow detailed written instructions and have good verbal/written communication skills. Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction. Must have passion to innovate and drive for solutions. Must display personal accountability for results and integrity. Must display eagerness to learn and continuously improve. Must have uncompromising dedication to quality Education and/or Experience:Bachelor's Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework with 0-2 years' experience. Appropriate additional certifications may be required pursuant to state or federal regulatory requirementsVacancy expired!