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Summary: This position includes responsibilities in two areas. One area is performance of tasks related to drug formulation, weighing, cleaning mix complex, tanks and equipment, distilled water sanitization, filter integrity testing and documentation. The other area is machine set-up operation and adjustments; which includes batch change over, sterilization, cleaning and batch documentation.
Essential Duties and Responsibilities:
- Run Galaxy Machine
- Set up equipment
- Perform sterilization
- Management of Dataloger output
- Troubleshoot alarms
- Make process adjustment in accordance with GMP’s and Plant Procedures
- Responsible for In-Process inspections and all related documentation in accordance to specifications
- Issue ports, build embosser, clean pressure vessel
- Perform line clearances
- Build and perform integrity testing on all production sterilizing filters
- Maintain area housekeeping
- Perform tasks related to drug formulation, weighing, cleaning the mix complex, tanks and equipment, distilled water sanitation, filter integrity testing and documentation necessary for traceability according to specifications and procedures
- Perform drop sanitization
- Required to maintain attendance in accordance with the RLD Attendance Policy
- Mandatory overtime required
Work Environment: Work with pressurized equipment, -25o to -70o F room temperature, work with hot surfaces, wet environment, work with chemicals and drug compounds.
Qualification Requirements:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions:
- Ability to work independently
- Requires the use of and troubleshooting of the label and directional insert dispensing equipment
- Good communication skills
- Good documentation skills
- Good interpersonal skills
- Good computer skills
- Knowledge of standard operating procedures, specifications, and job-specific training materials
Education and/or Experience: High School Diploma or equivalent, experience in GMP Mfg.
Language Skills: Must be able to understand, speak, read and write English in order to comply with necessary SOP’s, SPEC’s, Job-specific training materials, GMP’s, and other manuals.
Mathematical Skills: Basic math skills required.
Reasoning Ability: Decision making in this position is based on existing standard operating procedures as well as ability to use good judgment. A high level of independent decision making and responsiveness is necessary for this position and may include releasing of product, scheduling, etc. This person must have the ability to work independently, and the ability to evaluate appropriate resources for problem resolution. Resources used may include supervisors, managers, engineering, quality management, specifications, SOP’s and manuals.
Other Skills and Abilities:
- Requires the operation of multiple types of equipment related to the mix and fill operation as well as hand operated equipment, but not limited to, such things as calipers, scales, gauges, and other measuring devices.
- Requires the ability to demonstrate the proficiency in reading of gauges, blueprints, calibrated cylinders and templates.
Physical Demands:
- Must not be allergic to Penicillin or Cephalosporin Drugs.
- Visual acuity 20/30 Near Vision with or without corrective vision required.
- Frequent lifting of up to 25 pounds, occasional lifting of 50 pounds.
- Frequent pushing and pulling of 15-40 pounds.
- Frequent walking, bending, standing, stooping, squatting, and climbing of step/ladders.
- Frequent movement of the hands and wrist and have the ability to reach up and out
- Wear a respirator
- Work in confined spaces
- Wear protective equipment
- Work with pressurized equipment, hot surfaces
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
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 to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
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