Shift 1 (8am-5pm) and 3rd – (11pm-7am) – only when certain products are produced
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
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
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
Other Duties as Assigned
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Overtime is worked as required.
Quality Lab Associate I
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Quality Control Investigation Writer
On site
1 Year
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