Performs a variety of chemical tests and is knowledgeable with instrumental techniques. Responsible for sampling, monitoring, and testing process water quality, as well as check other analyst's documentation. Relies on work instructions and pre-established guideline to perform the functions of the job. Work responsibilities must be performed in accordance with regulatory and industrial standards, and in a timely manner with a high regard for safety and quality. Employee must demonstrate understanding of cGMP, cGLP, USP, and AAMI/ANSI requirements for medical device product manufacture and testing. Works under the immediate supervision of the Quality Control Supervisor.
Responsibilities include, but are not limited to:
Operate the ICP-OES, Flame AA, Polarimeter, Acid titrator, LAL and other analytical instruments.
Prepare and qualify test standard solutions.
Scheduled daily tasks to be performed in an efficient manner.
Produce analytical work in accordance with all applicable SOPs and approved analytical methods.
Accurately records raw data in logs and worksheets. Interprets and documents all test results, calculations and completes report summaries.
Judges the accuracy of test results. Recognizes OOS/OOT or suspect results and promptly reports them to QC Supervisor.
Assists and works with the QC Supervisor in completing laboratory investigations.
Perform routine lab equipment calibration and maintenance activities.
Expectations/Other skills for this position:
Safe and efficient equipment operation
Strictly comply with Standard Operating Procedures and GMP practices and guidelines
Communicate with supervisor and other employees about potential problems or improvements
Work well in a team environment, coach/motivate other employees
Commitment to continuous improvement
Support company culture of quality, accountability, efficiency and teamwork
Previous experience in a manufacturing environment
Knowledge of FDA regulations for medical device/pharmaceutical
ASQ or other laboratory certification preferred
BS in Science or related degree with at least 1 year of laboratory experience.
Experience in the pharmaceutical with FDA guidelines preferred.
Must demonstrate appropriate written and verbal communication skills.
Must demonstrate competency in the operation, maintenance, performance qualification, and troubleshooting of laboratory equipment.
Must be able to follow written instructions with keen attention to detail.
Willing to work shifts, including weekends/overtime as required
Final candidate must be willing to submit to background/drug check
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