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).
Chemist I
Essential Functions:
Inspects components, products and/or processes to ensure conformance with standards.
Executes laboratory procedures for sample preparation.
Performs materials analysis of substantial variety & complexity using ARx test methods, compendia methods, specifications with minimal supervision.
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.
Recommends / initiates modifications of existing quality or production standards to achieve optimum quality with the equipment's capability.
Provide support to routine USP water and environmental testing.
Works with minimal supervision/direction in expediting completion of laboratory assignments.
Assists in investigation of out-of-specification (OOS) or out-of-trend (OOT) results.
Trains and/or mentors lower level chemists.
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.
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.
Performs other duties and responsibilities as assigned.
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.
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).
Requires a Bachelors (or higher) degree in Chemistry, Microbiology or closely-related discipline (Analytical Chemistry preferred) plus a minimum of 3 years related experience.
Knowledgeable in the application of various analytical techniques such as chromatography and spectroscopy; thermal analysis and wet chemistry techniques desired.
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.
Basic 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; specially in the operational use of analytical equipment have a computer interface.
Ability to perform basic mathematical functions and apply basic concepts such as mean and standard deviation.
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.