5 compliance testing jobs found in Vernon Hills, IL

Job Title: QC Manager MicrobiologyJob Description The QC Manager Microbiology is responsible for managing microbiology quality control operations, ensuring compliance with cGMP and regulatory standards. This role involves overseeing sterility, bioburden, endotoxin, and environmental monitoring testing, reviewing data for accuracy, and collaborating with Quality Assurance on investigations and SOPs. The manager will lead a team, drive continuous improvement, and ensure timely batch release decisions. Responsibilities Manage microbiology QC team and daily laboratory operations. Review microbiology data, such as sterility, bioburden, and environmental monitoring, from LIMS/e-notebooks. Collaborate with Quality Assurance on SOPs, investigations, CAPAs, and deviations. Ensure compliance with FDA, USP, EU, and ISO guidelines. Oversee media preparation, instrument validation, and calibration. Analyze QC metrics and performance indicators for...

Job Title: QC ManagerJob Description The QC Manager will oversee QC chemistry operations, focusing on analytical testing, particularly HPLC/UPLC and data integrity. This role involves reviewing potency, purity, and identity data, managing method transfers, and ensuring compliance with FDA, USP, and ICH guidelines. The manager will provide technical leadership and support quality initiatives across departments. Responsibilities Supervise chemistry QC analysts and day-to-day lab testing. Review analytical chemistry data (potency, purity, identity) using LIMS or Empower. Develop and enforce SOPs, deviations, and CAPA processes. Ensure cGMP compliance (FDA, USP, ICH, ISO). Oversee equipment validation/calibration, and method transfers. Manage QC metrics, trending, and batch dispositions. Provide technical training and mentor the QC team. Coordinate with QA and cross-functional teams on data and quality issues. Essential Skills...

Job Title: Microbiology Data ReviewerJob Description The Microbiology Data Reviewer is responsible for reviewing microbiological data generated from laboratory testing to ensure accuracy, completeness, and compliance with cGMP, company policies, and regulatory requirements. This role supports quality assurance processes by identifying discrepancies, ensuring proper documentation, and collaborating with cross-functional teams to maintain high standards of data integrity. Responsibilities Routinely communicate with laboratory staff, Quality Assurance, and other departments regarding data review, corrections, issues, and solutions. Ensure documentation of microbiological experiments and testing is accurate and in accordance with company policies and procedures. Collaborate with Quality Assurance to develop and refine procedures that support quality activities and regulatory compliance. Review microbiology data from ongoing testing, spreadsheets,...

Job Title: R&D Specialist Job Description We are seeking a dedicated R&D Specialist to join our team and contribute to the development of new products and technologies within the R&D group. This role will focus primarily on Laboratory Information Management Systems (LIMS) due to our current system upgrade and the need to review all stability studies. As a subject matter expert in Stability, you will facilitate project needs and help manage a backlog of over 300 studies. The position involves handling non-routine studies, requiring analytical thinking and problem-solving skills for new product-related stability studies. Responsibilities Conduct LIMS review of stability studies. Plan and execute or facilitate stability testing to support product claims. Author and review stability protocols and reports. Track, compile, and review results needed for product requirements and regulatory submissions such as 510k's, CE technical files, and...

This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/jobs/13175268 Our client in the retail space is looking for a part time Product Manager to join their team kicking off in January. This is an exciting opportunity for a highly organized, detail oriented candidate to assist with getting various product lines approved for compliance and safety testing. To be considered for this opportunity you must be local to the Northern Suburbs of IL with the ability to come on site as needed. The Product Manager will be responsible for:\ Ordering and tracking samples to ensuring they are shipped to the testing facility which will include communicating with suppliers\ Day to day communication with the testing facility, suppliers and internal team members\ Managing multiple timelines with tight deadlines The Product Manager must have:\ Monday.com experience\ Strong...