Senior Quality Specialist
Senior Quality Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Applies GMP/GLP in all areas of responsibility as appropriate
- 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 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
- 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
Qualifications :
Basic Minimum Qualifications:
- Bachelors degree in a science-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)
- Minimum of three years of Pharmaceutical laboratory experience with knowledge of regulatory requirements
- Computer skills including word processing spreadsheets PowerPoint and database is a plus
- Experience with cGMP and/or FDA regulated environments is a plus
- Authorization to work in the United States indefinitely without restriction or sponsorship
Preferred Qualifications:
- Experience in performing Pharmaceutical analytical testing
- Computer skills including word processing spreadsheets PowerPoint and database is a plus
- Experience with cGMP and/or FDA regulated environments is a plus
Additional Information :
Position is full-time Monday-Friday 8am-5:00pm plus additional hours as needed. Candidates 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 USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
