Job Summary

Provide analytical support and data generation for daily chemistry testing activities related to raw materials, in- process and finish products. Perform all testing in a timely and accurate manner in accordance with approved GMP documents (test methods, Specifications, SOPs).

Must be able to work M-F 10am-6pm, and training provided on dayshift.

Chemist I

Chemist II

Essential Functions:

• Inspects components, products and/or processes to ensure conformance with standards.

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• Executes laboratory procedures for sample preparation.

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• Performs materials analysis of substantial variety & complexity using ARx test methods, compendia methods, specifications with minimal supervision.

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• Ensure all analytical operations comply with cGMPs & ARx procedures and all laboratory experiments are properly documented in notebook and are in accord with regulatory requirements.

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• Conducts method qualification, validation projects work from established documents using basic analytical techniques.

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• Participates in the execution of validated test method transfer protocols.

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• Recommends / initiates modifications of existing quality or production standards to achieve optimum quality with the equipment's capability.

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• Provide support to routine USP water and environmental testing.

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• Works with minimal supervision/direction in expediting completion of laboratory assignments.

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• Assists in investigation of out-of-specification (OOS) or out-of-trend (OOT) results.

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• Trains and/or mentors lower level chemists.

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• Abide by the ARx Laboratory Chemical Hygiene Plan and other safety policies. Maintains a safe and clean work environment, notifying the supervisor of unsafe practices, conditions, or acts; L-II takes on increasing responsibility for surfacing and implementing improved safety practices.

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• Responsible for following all applicable waste handling procedures.

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Additional Responsibilities:

• Completes required paperwork / documentation accurately, neatly and in a timely manner.

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• Effectively communicates with other associates, supervisors and various co-workers; relays information to the next shift (as needed); voluntarily assists other associates; communicates effectively to prevent problems from occurring.

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• Interacts with and/or participates on cross-functional product development teams.

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• Responsible for the proper disposal of hazardous waste into the proper labeled containers and drums.

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• Performs other duties and responsibilities as assigned.

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• Make identifiable and substantial contributions to continuous improvement. Performs all duties consistent with established ARx guideline consistent with all regulatory requirements. Actively complies with and endorses Department and Company objectives.

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Job Specifications:

• BS (or higher) degree in Chemistry, Microbiology, or closely related discipline and 0-2 years lab experience (preferably pharmaceutical GMP) or requires high school education and 5 years minimum lab experience (preferably pharmaceutical GMP).

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• Requires a Bachelors (or higher) degree in Chemistry, Microbiology or closely-related discipline (Analytical Chemistry preferred) plus a minimum of 3 years related experience.

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• Knowledgeable in the application of various analytical techniques such as chromatography and spectroscopy; thermal analysis and wet chemistry techniques desired.

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• Knowledgeable and proficient in application of gas chromatography (headspace, high-pressure liquid & gel permeation), UV-VIS-FTIR spectroscopy, TOC, thermal and mechanical analysis (e.g. DMA, DSC, etc); wet chemistry techniques desired.

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• Basic knowledge and understanding of scientific principles involved in the performance of analytical test methods.

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• Ability to troubleshoot and perform basic maintenance to ensure optimum performance of instrumentation.

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• Evidence of continuing education such as professional certification (i.e., ASQC) or college level courses related to the position.

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• Ability to efficiently utilize time (coordinate several assignments concurrently).

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• Ability to read and interpret documents such as test methods and procedure manuals.

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• Knowledge of requirements for maintaining proper laboratory
  otebook documentation

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• Must have above average computer skills and knowledge; specially in the operational use of analytical equipment have a computer interface.

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• Ability to perform basic mathematical functions and apply basic concepts such as mean and standard deviation.

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• Good communication skills (verbal and written).

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• Excellent interpersonal skills.

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• Requires common physical characteristics and abilities, such as above average agility and dexterity; physical exertion such as long periods of standing, recurring bending, crouching, stooping, stretching, reaching or similar activities should be expected.

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• Work environment involves moderate risks or discomforts requiring special safety precautions, will be required to use personal protective equipment.

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