Job Description

Job Summary

Provides expert 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). Conducts investigations, drafts and executes protocols.

Essential Functions

• Inspects components, products and/or processes to ensure conformance with standards.
• Executes laboratory procedures for sample preparation.
• Independently performs materials analysis of substantial variety & complexity using ARx test methods, compendia methods, specifications.
• 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.
• Conducts method qualification, validation projects work from established documents using basic analytical techniques.
• Participates in the execution of validated test method transfer protocols; drafts & independently executes protocols.
• Recommends / initiates modifications of existing quality or production standards to achieve optimum quality with the equipment’s capability.
• Works independently to accomplish same and assists management in prioritization as needed.
• Conducts investigation of out-of-specification (OOS) or out-of-trend (OOT) results.
• Trains and/or mentors lower level chemists.
• Specializes and acts as lead expert in particular areas of quality control (e.g. methods, method development, statistical process control, etc.).
• 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; takes on increasing responsibility for surfacing and implementing improved safety practices.
• Responsible for following all applicable waste handling procedures.

Additional Responsibilities

• Completes required paperwork / documentation accurately, neatly and in a timely manner.
• 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.
• Interacts with and/or participates on cross-functional product development teams.
• Responsible for the proper disposal of hazardous waste into the proper labeled containers and drums.
• 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.
• Performs other duties and responsibilities as assigned.

Job Specifications

• Requires a Bachelors (or higher) degree in Chemistry or closely related discipline (Analytical Chemistry preferred) plus a minimum of 5 years related experience.
• 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.
• Mastery knowledge and understanding of scientific principles involved in the performance of analytical test methods.
• Ability to troubleshoot and perform basic maintenance to ensure optimum performance of instrumentation.
• Evidence of continuing education such as professional certification (i.e., ASQC) or college level courses related to the position.
• Ability to efficiently utilize time (coordinate several assignments concurrently).
• Ability to read and interpret documents such as test methods and procedure manuals.
• Knowledge of requirements for maintaining proper laboratory otebook documentation.
• Must have above average computer skills and knowledge; specifically in the operational use of analytical equipment have a computer interface.
• Ability to perform basic mathematical & statistical functions; capable of designing and drafting test method transfer protocols as well as executing same and writing related reports.
• Ability to apply basic statistical process control concepts such as control charting.
• Good communication skills (verbal and written).
• Excellent interpersonal skills.
• 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.
• Work environment involves moderate risks or discomforts requiring special safety precautions, will be required to use personal protective equipment.

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