Amanda Oliger Schafer, Bsc, Rqap-Glp

Amanda Oliger Schafer, Bsc, Rqap-Glp Email and Phone Number

Quality Assurance Supervisor at Inotiv @ Inotiv
Amanda Oliger Schafer, Bsc, Rqap-Glp's Location
Gaithersburg, Maryland, United States, United States
Amanda Oliger Schafer, Bsc, Rqap-Glp's Contact Details

Amanda Oliger Schafer, Bsc, Rqap-Glp work email

Amanda Oliger Schafer, Bsc, Rqap-Glp personal email

n/a
About Amanda Oliger Schafer, Bsc, Rqap-Glp

Quality Assurance Supervisor with experience in the following: 21 CFR Part 58, 21 CFR Part 11, 40 CFR Part 160, 40 CFR Part 792, OECD Series on GLP and Compliance Monitoring, GMP, ISO 17025:2017, CAP and CLIA. Experience in the following: CAPA, deviations, phase inspections of non-clinical laboratory studies/protocols/reports, writing/reviewing/approving SOPs, training new employees, providing annual GLP refresher trainings, oversight of external data transmission to clients, internal facility/equipment audits, external supplier/subcontractor audits, archival of QA data, document control. Skills: document control, auditing, writing, communication, organization, training, leadership

Amanda Oliger Schafer, Bsc, Rqap-Glp's Current Company Details
Inotiv

Inotiv

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Quality Assurance Supervisor at Inotiv
Amanda Oliger Schafer, Bsc, Rqap-Glp Work Experience Details
  • Inotiv
    Quality Assurance Supervisor
    Inotiv Jun 2023 - Present
    West Lafayette, In, Us
  • Cvpath Institute, Inc.
    Lead Quality Assurance Specialist
    Cvpath Institute, Inc. Jun 2021 - Jun 2023
    Gaithersburg, Md, Us
    Supervised QA Associate staff. Monitored non-clinical laboratory studies to assure conformance to GLP and OECD regulations.Maintained laboratory compliance with GLP and CAP regulations. Provided GLP training to new employees and maintained employee training files. Oversight of maintaining and creating new SOPs and Forms.Maintained the Master Schedule of all non-clinical studies.Audited all GLP studies to include phase inspections and final reports. Prepared and signed the QA Statement for GLP final reports. Assured compliance with 21 CFR Parts 58 and 11. Evaluated protocols for GLP and OECD compliance for non-clinical laboratory studies.
  • N/A
    Quality Assurance Specialist
    N/A Nov 2020 - May 2021
    Studying to further my knowledge and career: Python, Six Sigma, GMP, GLP, FDA, EPA.
  • Bayer Crop Science
    Quality Assurance Specialist
    Bayer Crop Science Jul 2020 - Oct 2020
    Leverkusen, North Rhine-Westphalia, De
    Developed a quality assurance plan, consisting of a grading system for determining plant health, for the Agronomy Plant Health Team.Monitored plant health by performing water and soil analysis.Assisted in developing company standard operating procedures.
  • Atlas Bioscience Labs Llc
    Quality Technician
    Atlas Bioscience Labs Llc Aug 2019 - Jun 2020
    Provided oversight in an analytical laboratory that performed content analysis on dietary supplements. Performed internal audits to ensure adherence to company standard operating procedures and accreditation guidelines to be in compliance with ISO 17025:2017. Assisted with external audits, OOS investigations, and document reviews. Audited final reports. Trained to process and run samples on HP-LC, LC-MS, and GC-MS.*Atlas Bioscience Labs LLC was forced to close in June 2020 due to the sudden death of its owner Dr. Dinesh Patel.
  • Sonora Quest Laboratories/ Laboratory Sciences Of Arizona
    Cytology Preparatory Technician Ii
    Sonora Quest Laboratories/ Laboratory Sciences Of Arizona Jun 2017 - Aug 2019
    Phoenix, Arizona, Us
    Accessioned and processed biological specimens, both gynecological and non-gynecological, for microscopic evaluation by following company SOPs.Assisted with maintaining compliance with federal agencies including CLIA, CAP, and OSHA by assuring conformance of equipment, logbooks, and proper hazardous waste disposal. Assisted with training new employees.
  • Daikin North America
    Environmental Monitoring Technician
    Daikin North America Aug 2016 - May 2017
    Waller, Texas, Us
    Performed monitoring and maintenance to gas lines, compressors, pumps, and valves, in accordance with EPA’s Leak Detection and Repair Program, for a GMP-certified fluorochemical manufacturing facility. Verified compliance of all permits to be in accordance with the Clean Air Act, National Emission Standards for Hazardous Air Pollutants, and the Resource Conservation and Recovery Act. Monitored hazardous waste satellite accumulation sites for compliance. Monitored effluent by performing on-site water testing.
  • Applebee'S Neighborhood Grill + Bar
    Key Hourly Manager & Bartender
    Applebee'S Neighborhood Grill + Bar Aug 1999 - May 2017
    Pasadena, California, Us
    Cross-trained and certified as a hostess, server, bartender, cook, and key hourly manager.ServSafe Food Handler and ServSafe Alcohol certified.Supervised employees and assisted the general manager as needed.Trained new employees.

Amanda Oliger Schafer, Bsc, Rqap-Glp Skills

Auditing Accreditation Biology Quality Managements Systems Chemistry U.s. Health Insurance Portability And Accountability Act Complaint Management Water Testing Communication Change Control Laboratory Information Management System Standard Operating Procedure Leak Testing Laboratory Safety Geographic Information Systems Quality Assurance Clean Air Act Microsoft Office Accreditation Compliance Laboratory Skills Time Management Employee Training Customer Service Environmental Science Regulatory Compliance Environmental Compliance Epa Corrective And Preventive Action Ability To Interpret P&ids Management Teamwork Analytical Skills Chemical Safety Third Party Audits Good Laboratory Practice Iso Standards Information Management Environmental Monitoring Internal Audit

Amanda Oliger Schafer, Bsc, Rqap-Glp Education Details

  • University Of North Alabama
    University Of North Alabama
    Environmental Biology

Frequently Asked Questions about Amanda Oliger Schafer, Bsc, Rqap-Glp

What company does Amanda Oliger Schafer, Bsc, Rqap-Glp work for?

Amanda Oliger Schafer, Bsc, Rqap-Glp works for Inotiv

What is Amanda Oliger Schafer, Bsc, Rqap-Glp's role at the current company?

Amanda Oliger Schafer, Bsc, Rqap-Glp's current role is Quality Assurance Supervisor at Inotiv.

What is Amanda Oliger Schafer, Bsc, Rqap-Glp's email address?

Amanda Oliger Schafer, Bsc, Rqap-Glp's email address is ao****@****ath.org

What schools did Amanda Oliger Schafer, Bsc, Rqap-Glp attend?

Amanda Oliger Schafer, Bsc, Rqap-Glp attended University Of North Alabama.

What skills is Amanda Oliger Schafer, Bsc, Rqap-Glp known for?

Amanda Oliger Schafer, Bsc, Rqap-Glp has skills like Auditing, Accreditation, Biology, Quality Managements Systems, Chemistry, U.s. Health Insurance Portability And Accountability Act, Complaint Management, Water Testing, Communication, Change Control, Laboratory Information Management System, Standard Operating Procedure.

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