ARx QC Chemist - Microbial Specialist

Provides analytical support, data generation and data review for microbiological and analytical analysis. 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: Drafts and executes or participates in method transfer, qualification, verification and validation protocols; authors associated reports as required. Manages, in collaboration with QC, the effective transition of methods into routine quality testing. Perform routine and complex microbial and analytical wet chemistry analysis. Independently performs materials analysis of substantial variety & complexity as needed using ARx test methods, compendia methods, specifications. Manages the ARx Environmental Monitoring program including routine viable and non-viable monitoring as well as manages the USP Water monitoring program. Reports on an annual basis Environmental and USP water data including a review of any deviation events, change controls and any trends with resulting conclusions. Assist in the routine analysis of incoming raw materials for release testing for production use Ensures 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 and/or consults on investigation of out-of-specification (OOS) or out-of-trend (OOT) results where needed. Consults (where necessary) on new equipment specification, acquisition and qualification. 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 and proactively assists other associates as needed; anticipates and 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. Job Specifications: Requires a Bachelors (or higher) degree in Microbiology or closely related discipline plus a minimum of 2 years related experience. Proficient knowledge of microbiological and wet chemistry analysis. Knowledge of UV-VIS-FTIR spectroscopy, TOC, and other automated analysis is desirable. Extensive knowledge and understanding of scientific principles involved in the performance of analytical and microbiological test methods. Knowledge of requirements for maintaining proper laboratory notebook documentation. Ability to read and interpret documents such as test methods and procedure manuals. Ability to troubleshoot and perform basic maintenance to ensure optimum performance of instrumentation. Ability to apply basic statistical process control concepts such as control charting. Ability to efficiently utilize time (coordinate several assignments concurrently). Good communication skills (verbal and written) and 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.