Quality Lab Associate

Job Responsibilities

• Perform chemical quantitative and qualitative analysis on intravenous solutions, sets, devices, raw materials, and plant water (distilled, non-distilled water) utilizing ‘wet’ chemistry techniques and instrument analysis
• Use laboratory instrumentation, computer systems and software to collect and record data
• Must be able to use standard software applications such as MS Office Suite
• Perform analysis requiring precise analytical skills and understanding of chemistry principles
• Perform investigations utilizing problem solving and troubleshooting
• Prepare and perform protocols
• Investigate deviations and ability to write exception documents
• Ensure regulatory compliance
• Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP)
• Complete and peer-review documentation
• Complete all testing, including special projects / protocol testing in a timely and appropriate manner
• Must perform all other duties and responsibilities as determined by supervision/management
• Must have knowledge of both plant and department environmental health and safety regulations and comply with said regulations accordingly
• Must be able to work off shift hours and some weekends
• Must notify the supervisor and take appropriate action if any safety, quality, mechanical or discrepancy issues occur
• Must sustain a clean and safe work area using 6S principles

Knowledge, Skill and Abilities

• Computer competency, required
• Ability to work independently
• Good organizational and time management skills
• Good oral and written communication skills
• Ability to handle multiple priorities in a fast-paced environment

Physical Requirements

• Candidate must not be color blind as determined by the Isihara’s Test for Color Deficiency
• Candidates must meet near vision visual acuity requirements annually as documented in the Baxter-Cleveland Visual Acuity procedure

Required Education and Experience

• B.S. Degree in Science (Chemistry, Chemical Engineering, Physical Chemistry, Biology with Chemistry preferred)
• Quantitative analysis or equivalent lab experience
• Experience with instrumental analysis, required
• 2-4 Years experience