Analytical Chemistry, Auditing, Biology, Biotech and Pharmaceutical, Chemistry, Clinical Laboratory, Clinical Support, Clinical Trial, Contract Research Organization (CRO), Drug Development, Drug Manufacturing, Drug Metabolism, Environmental Protection Agency (EPA), FDA (Food and Drug Administration), GLP (Good Laboratory Practices), Laboratory, Life Insurance, Maintain Compliance, Pharmacodynamics, Pharmacokinetics, Pre-Clinical, Pre-Clinical Trials, Quality Assurance, Regulations, Research Laboratory, Research Protocols, Standard Operating Procedures (SOP), System Validation, Test Lab, Toxicology, Toxicology Research
QA Specialist/Auditor
Title: QA Specialist/Auditor
Location: Chicago, IL
Reports to: Senior Director of Quality Assurance
Full-time
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Our Chicago, IL site provides toxicology testing and research laboratory services and specialized pre-clinical studies in support of pharmaceutical and biotechnology products.
Position/Job Summary:
The individual in this position supports studies of the safety and/or toxicity of various materials (e.g., pharmaceuticals, chemicals, etc.). The QA Specialist/Auditor monitors study activities, facilities, equipment, personnel, procedures, and pertinent records to ensure that they satisfy appropriate domestic and international Good Laboratory Practice regulations, customer specifications and the company's standard operating procedures.
Roles & Responsibilities:
- Work under the supervision of the Senior Director of Quality Assurance.
- Conduct audits of pre-clinical toxicology or analytical chemistry studies to ensure strict compliance with GLP (FDA, EPA, OECD and JMHW) regulations, Study Protocol, and Company's SOPs.
- Audit study reports and records for completeness and consistency to confirm that reported results reflect the raw data and study methods. Identify compliance weaknesses and assist with the implementation of workable solutions.
- Inspect subcontractor facilities to ensure compliance with GLPs. Serve on various internal committees (e.g., computer validation, SOP review, etc.) to provide a QA perspective on the issues discussed.
Education, Experience & Skills Required:
- Must have a minimum of BS/BA degree in basic or applied science (biology, chemistry, etc.) with at least 1-2 years of experience in the conduct of GLP audits.
Salary: $65-75k
Benefits:
- 401k Employer Match with immediate vesting
- Vision Insurance
- Medical and Dental Insurance with multiple coverage options
- FSA (Medical, Dependent Care, and Commuter)
- Short Term Disability
- Long Term Disability
- Life Insurance
- Generous Paid Holidays and PTO
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.