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 Bachelors 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 chemistryrelated terms
- Basic understanding of ISO/EN/USP standards and guidelines.
- Some qualityrelated work experience is preferred.
Additional Information :
Position is fulltime MondayFriday 8 a.m.5 p.m. with overtime as needed.
Budgeted Salary range for this role is $20.00 $25.00/hr based on experience
Excellent fulltime 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.
Remote Work :
No
Employment Type :
Contract