Vacancy caducado!
Job Description
Quality Assurance Specialist responsibilities include, but are not limited to, the following:- Applies GMP/GLP in all areas of responsibility, as appropriate
- Demonstrates and promotes the company vision
- Regular attendance and punctuality
- Monitor laboratory compliance with respect to expired reagents, reagent labeling, lab cleanliness, training records, PPE adherence, and other cGXP items, as needed to help minimize laboratory audit findings.
- Perform/Support Internal audits, as well as help, implement the resolution of internal/external audit findings
- Review Instrument qualifications to ensure that work is performed as per the procedure
- Review GLP data for adherence to GLP regulations
- Review and verify invalid data and system suitability failures
- Review and close Exceptions under Non-Routine Events, System Suitability Failure, and Deviations
- Approve Analytical Method/Protocol/SMIS/Client Parameter per QA procedure
- Track and Analyze quality metrics (exception rate, rejection rate etc) and train laboratory personnel, as needed, to help reduce/eliminate rework
- Support other QA compliance-related activities, as needed
- Communicate in writing and in person with laboratory personnel in an intelligent and clear manner
- Diagnose problems, solve simple problems, and suggest solutions to complex problems in the professional area
- Keep oneself and peers abreast of current developments and trends in the professional area by reading and understanding internal procedures, attending training sessions, by writing/revising SOPs (as required), and by assisting Group Leader/Principal Specialists in training new employees
- Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process
- May serve as technical advisor for analysts with regard to QA/QC of data
- Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns
- Support other QA compliance-related activities, as needed
- Conducts all activities in a safe and efficient manner
- Performs other duties as assigned
Qualifications
Basic Minimum Qualifications:- Bachelor's degree in ascience-related field or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
- At least three years of laboratory experience with knowledge of regulatory requirements
- Authorization to work in the United States indefinitely without restriction or sponsorship
Additional Information
Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply.
- 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 aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
Vacancy caducado!