Associate Scientist

Integrated Resources, Inc

Chicago Heights, Illinois

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JOB DETAILS

JOB TYPE

Contractor

SKILLS

Administrative Skills, Analysis Skills, Analytical Chemistry, Analytical Method Development, Analytical Method Validation, Chemistry, Chromatography, Code of Federal Regulations, Communication Skills, Cross-Functional, Data Analysis, Detail Oriented, Develop Methodologies, FDA (Food and Drug Administration), Fourier-Transform Infrared Spectroscopy (FTIR), GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), High Performance Liquid Chromatography (HPLC), Identify Issues, Instrumentation, Integrated Circuits (ICs), Laboratory, Laboratory Testing, Mentoring, Presentation/Verbal Skills, Production Support, Quality Control, Regulations, Regulatory Submissions, Reporting Skills, Safety/Work Safety, Sales, Standard Operating Procedures (SOP), Testing, UV/VIS (Ultraviolet-Visible Spectroscopy), Veterinary Medicine, Writing Skills

LOCATION

Chicago Heights, Illinois

POSTED

1 day ago

Associate ScientistAnalyze and/or direct the analysis of routine and non-routine samples without supervision including but not limited to raw materials, in process testing, finished good release and stability testing.Coordinates activities associated with production and quality activities.Be responsible for approval of analytics associated with quality control testing in the laboratory.Trains or mentors others in routine analyses.Assists in the development of studies and proceduresCreates and leads experiments with minimal supervision from managementSupports the site quality, safety and production needs and goals compliantlyAssume responsibility for the primary scientist lead at the siteFamiliar with laboratory environment as well as responsible for knowledge of (Veterinarian Master File) VMFs, NADAs, Regulatory Submissions, CFR 211/226 regulations and filing specifications.Develops, runs/directs, routine lab activities as well as experiments, studies, and projects in support of production, laboratoryGathers sufficient information from all sources to fully understand study, site and/or customer needs, Uses proper study design to effectively utilize resources, Plans studies, including timeline to followCompiles, analyzes, and interprets data leading to reports with conclusions and recommendations to appropriate personnelUnderstands and follows GMP/GLP regulations.May supervise non-exempt and contract personnel to achieve above goalsMay work with senior scientific or management staff on major studies assuming scientific and GMP responsibility for a portion or portions of the study, Includes cross functional and cross site teamsKeeps abreast of technological advances specific to the laboratory and adopts and develops new techniques or scientific methods based on findings.Maintains Standard Operating Procedures dealing with their work area and recommends new methods and procedures for their area and the laboratory.Provides recommendations, conclusions and direction based on the data obtained from studies.Maintains a safe and clean working area, and directs others in same.Ability to communicate within department, with vendors, contractor sites and/or external customers for administrative and technical information.Ability to prepare reports of experiments or studies that are grammatically and technically ready for regulatory auditAbility to construct and format reports for the intended audience (i.e. FDA, Production, Laboratory, Customers, or Sales).May support FDA filings, assisting in compiling FDA responses, annual compliance reports, provide review for regulatory submissions.May support release of finished goods including technical review of batch records, labelling and COA generation and/or approval.BS or higher in related scientific field, preferably in an FDA regulated environment.Approximately 5-10 years laboratory experience.7+ years of experience with GLP1-3 years of experience with FDA regulationsExcellent attention to detail, excellent written and verbal skillsProficient in chemistry and analytical instrumentation including but not limited to HPLC, IC, GC, FTIR and UV-VIS spectroscopy.Experience with Wet Chemistry bench methodsAbility to troubleshoot issues as it relates to methods and equipment/instruments.Experience with analytical method development and validation.Ability to develop, run/direct, and report experiments, studies, and projects in support of laboratory, customer, validation & productionExperience with instrumental software, i.e. Shimadzu Class VP, LC Solutions, Empower Chromatography Data SystemRegards, Ricky Bansal732-429-1925

Associate Scientist

Integrated Resources, Inc

Chicago Heights, Illinois

About the Company

Integrated Resources, Inc

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