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

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.

Budgeted Salary range for this role is $25.00-27.00/hr based on experience

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.