Baxter Quality Lab Associate III, Supervisor Raw Material in Marion, North Carolina
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Conduct biological, chemical and physical analyses on pharmaceutical products and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods, and environmental monitoring programs. Write and execute validations for manufacturing processes and laboratory instruments and methods.
· Conduct biological, chemical and physical analyses on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs and Baxter manufacturing facility.
· Write and execute validations for manufacturing processes and laboratory instruments and methods.
· May serve as mentor to other Quality Laboratory positions. Provide training and work direction for Quality Laboratory Associate II positions as required. Manage work flow and laboratory release functions in specified laboratory areas and on off shifts.
· Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems.
· Use sophisticated laboratory instrumentation and computer systems to collect and record data. Perform advanced laboratory assays requiring precise analytical skills and understanding of scientific principles.
· Work on special projects / protocol testing that involves new methods and instrumentation. 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. Investigate deviations and write exception documents.
· Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.
· Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.
· Perform equipment maintenance and calibrations as required. Troubleshoot and resolve instrument problems.
· Proficient in advanced wet and instrumental methods of analyses.
· Ability to handle multiple tasks concurrently, and in a timely fashion.
· Computer literate.
· Must be able to communicate effectively with managers, peers and subordinates.
· Strong leadership, organization and time management skills, and ability to handle multiple tasks.
· Must demonstrate effectiveness in ability to train others, empowerment, results oriented and task completion.
· Decision-making and technical problem solving ability is a plus.
Bachelors Degree in Chemistry or biological science with minimum of 5 years experience, or Masters Degree in Chemistry or biological science with 1-4 years experience.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law EEO is the law - Poster Supplement Pay Transparency Policy
Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail toAmericas_TTA@baxter.comand let us know the nature of your request along with your contact information.
Organization: *Global Operations - Manufacturing
Title: Quality Lab Associate III, Supervisor Raw Material
Location: North Carolina-Marion
Requisition ID: 190000DP