Quality Assurance Specialist Seasonal
Eurofins USA BioPharma Services - san diego, CA
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Job Description The Quality Assurance Specialist will be responsible for routinely reviewing analysis reports to ensure their accuracy, completeness, and compliance with internal/external guidelines. As part of this review, candidates will identify/initiate CAPAs, Deviations, Change Controls, Process Improvements, and Root Cause Analysis. Perform a review of test data as it relates to QC microbiological and/or analytical chemistry testing. Review records for GMP compliance and consistency with company policies and procedures necessary to support customers' quality requirements. Maintain data integrity in assigned areas and/or systems and ensure compliance with company SOPs and specifications, as well as FDA, ISO, and cGMP regulations. Use computerized systems for approving test results. Employ the use of databases and related systems used for tracking various GMP activities. Ensure individual training requirements are met and that training records are current. Maintain document control and training program records. Support quality event investigation activities as directed. Support internal audits as necessary Participate in training and development activities to advance core competencies and quality knowledge. Actively contribute to the team setting within the laboratory. Other duties as assigned by departmental management. Qualifications: Qualifications Education: A Bachelor's degree in chemistry, biological science, or another related field. Experience: 1 to 3 years of industry experience Knowledge of Regulatory Requirements Basic understanding of microbiology and/or chemistry-related terms Basic understanding of ISO/EN/USP standards and guidelines. Some quality-related work experience is preferred. Additional Information Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed. Excellent full-time benefits including comprehensive medical coverage, dental, and vision options Life and disability insurance 401(k) with company match Paid vacation and holidays Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
Created: 2024-10-17