$40K - 60K a year
Maintain lab quality management system, perform analytical testing, generate SOPs, conduct environmental monitoring, participate in CAPA and change control, assist audits and regulatory activities.
Requires 2-year degree in chemistry or chemical engineering, knowledge of GLP, cGMP, good communication, documentation skills, and preferably bilingual English/Spanish.
Job Description Although Corporate Quality Assurance is responsible for overseeing the Quality Assurance program, all personnel have defined roles and responsibilities and should be familiar with this SOP. Note that roles at some facilities may overlap. The roles and responsibilities should be used as a guide to ensure that personnel are qualified by education and training to accomplish their respective jobs. Description RESPONSIBILITIES (Include Responsibilities, Decisions, And/or Recommendations For Each Task) Frequency (Daily, weekly, monthly, quarterly, annual) Maintain the Laboratory Quality Management System. Daily Maintain Safety Data Sheets (SDS) program: hard and e-copy files routine updates. Daily Perform and document analytical testing of raw ingredients, in-process goods, packaging materials, customer complaint and returned goods samples. Daily Assist in maintaining QC Laboratory in audit-ready state and cGMP compliant. Maintain smooth laboratory functionality. Daily Generates Standard Operation Procedures (SOPs) for new test methods, quality, and operational requirements. Daily Trains and document training on new methods and requirements. Daily Conducts environmental monitoring of water, air quality, production area temperature. Monthly Document/report results as required. Report any non-conforming results to QA Manager and Production Supervisor. As Needed Routine inspections of Finished Goods (FGs) and components to ensure product conformance to standards: Appearance, Color, Lot Codes, Defect Levels, Incoming/New Label Approvals etc. Daily Member of Corrective Action and Preventative Action (CAPA) Team: A. Perform non-conformance investigations. B. Re-inspections, retesting, identifying FG warehouse locations and quantities (Internal and External). C. Perform lot code searches and product recovery. D. Report all findings to Quality and Operations Management. E. Document corrective and preventative actions. Follow-up monitoring to gauge the effectiveness of the corrective action. As Needed Member of the Change Control Board: A. Assist CCB Moderator (QC Manager) in documenting and communicating follow-ups to change control requests. B. Assist in Change Control Coordinator and properly document any new change request using the appropriate form and prepare meeting notes for publication. As Needed Promote good customer relations: A. Takes the lead in New Product Trials and Start-up (ensuring all required documentation is received and communicated as necessary). B. Validate new customer test methods and instrument techniques as required. C. Train QC personnel o methods and instrument techniques as required. As Needed Assist in maintaining the Quality Hold Program. Daily Assist in conducting Quality System Audits (Internal/External) and reports results to QA Manager. As Needed Communicates quality concerns to Operations Team and assists in determining root cause analysis. As Needed Complies, interprets data, and reports results to QC Manager. Daily Assist in regulatory activities (domestic and international) as needed. As Needed Qualifications Quality Assurance recommends a minimum of a 2-year degree in chemistry or chemical engineering, with excellent mathematics and problem-solving skills. Technical background and/or experience in Quality Assurance a plus. 2. Bachelor of Science Degree in Chemistry or Biology. 3. Good Documentation Practices (GLP). 4. Good Laboratory Practices (GLPs). 5. Effective Communication Skills: written, verbal and behavioral. 6. Current Good Manufacturing Practices (cGMP). 7. Good decision making and good troubleshooting skills. 8. Bilingual English/Spanish preferred. 9. Knowledge of Microsoft Office, particularly Word and Excel. 10. Document Control experience (Preferred). 11. Critical thinking skills.
This job posting was last updated on 9/19/2025