Quality Lab Associate I

Job Description

Duties and 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.

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.

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.
• HPLC Experience Preferred.

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.