Senior Production Technician

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 Baxter manufacturing facilities, etc.
• Use sophisticated 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.
• Perform Final Quality Release of all product
• Complete all testing, including special project / protocol testing in a timely and appropriate manner.
• Initiate and obtain applicable approval for test requests
• May maintain inventory/supplies necessary to conduct routine testing
• Follow continuous improvement practices (QLP, 5S, LEAN, etc.)
• Performs equipment maintenance and calibrations as required.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Perform release functions in LIMS or other computerized systems.
• Writes exception documents.

Qualifications:

• Proficient in wet and instrumental methods of analyses.
• Advanced laboratory skills and basic knowledge of statistical method.
• strong technical problem solving skills
• Ability to handle multiple tasks concurrently, and in a timely fashion.
• Must communicate effectively (verbal and written) with supervisors and peers.
• Must demonstrate effectiveness in ability to train others
• Experience in Aseptic Technique and Microbiological Methods
• Knowledge of most laboratory equipment including but not limited to autoclaves, incubators, analytical equipment
• Must be proficient in a variety of mathematical operations and calculations and be able to work with both the metric and US standards of measurement.
• Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
• Knowledge of basic chemical and biological safety procedures.
• Good computer skills, knowledge of Microsoft Word, Excel and Powerpoint.

Skills:

• Aseptic Filling
• Cleanroom
• Batch Record Review
• Quality Systems