Description:
Position Summary
The Chemistry Analyst I will work under direct supervision or be partnered with an experienced analyst to perform wet chemistry analyses, preparation of reagents, standardization of solutions, and instrumentation testing and documentation in a cGMP environment. May be cross-trained to work in other laboratory areas as dictated by the needs of the department.
Essential Duties & Responsibilities
Chemical analysis utilizing the following techniques: serial dilutions and pipetting
Instrumental analysis utilizing the following instrumentation: pH, HPLC, FT-IR, APTT
Chemical analysis testing such as Specific Gravity and Nonvolatile testing
Support media and chemical production for BQA laboratory and manufacturing areas.
Generate accurate lab records of tasks completed and verify the results of other lab personnel.
Keep the standardization of all laboratory volumetric solutions and preparation of all reagent solutions current.
Responsible for laboratory safety and GMP/GLP practices.
Interface with other departments when necessary for the reporting/recording of data.
Investigate questionable or inconsistent results and report to the supervisor. Participate in an evaluation and clarification of the problem and provide suggestions for its resolution.
Operate and maintain laboratory instruments, performing standardizations according to SLPs, STMs, and SOPs.
Make accurate records of tasks performed and data obtained. Prepare and maintain accurate and timely reports of progress and results.
Complete monthly room check to verify laboratory chemical expiration dates and calibration dates are within range.
Responsible for daily housekeeping, organization, and lab safety.
Adhere to cGMP's, SOP's and plant policies/guidelines.
Evaluate analytical data to determine compliance with established specifications.
Resolve routine analytical and quality problems, generally with limited assistance.
Work with personnel from other departments in the resolution of quality and analytical problems.
Support projects as assigned.
Perform other related duties as assigned or required.
Knowledge & Skills
Must be able to use mathematics to solve routine problems and manipulate algebraic equations on a daily basis.
Must be able to perform tests quickly and efficiently without sacrificing accuracy, safety or quality.
Must be able to operate and use an electronic and serological pipette.
Minimum Qualifications, Education & Experience
Must be at least 18 years of age
Associates degree preferred with chemistry emphasis
0-2 year of experience preferred. Prefer either one year of laboratory experience in a regulated industry OR one year analytical instrumental laboratory experience OR one year academic laboratory experience.
Work Environment
Types of problems encountered: Individual will generate data that will be used as the criteria in the decision to continue or stop manufacture of solutions and filling process.
Must be able to work flexible schedules, including overtime, in response to work demand. Typical schedule is Monday-Friday from 8/9AM to 4/5PM with 2 paid 10 minute breaks.
Office and laboratory environment.
Must be able to lift 20 lbs. unassisted.
Typically requires travel less than 5% of the time
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Additional Details
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