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 NonRoutine 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 compliancerelated 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 sciencerelated field or equivalent directlyrelated experience (two years of directly related industry experience is equivalent to one fulltime 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 :
Positions are fulltime working (MondayFriday 8:00am5:00pm) overtime as needed. Candidates currently living within commutable distance to 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
What Happens Next
Our people are the backbone of what we do so its incredibly important we find the right individuals to join us. As a potential new recruit youll be invited to meet the team in the form of an assessment centre or a staged interview process dependent on the role and its requirements this will give you the opportunity to see what working for Eurofins is really like and enable us to get you know your key skills and strengths.
Your data
As part of any recruitment process the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations.
Closing Date
We reserve the right to close or extend this position depending on application numbers. Therefore we would urge candidates to submit an application as early as possible.
Due to the high volume of applications we receive please be aware that if you do not receive a response within 4 weeks of the vacancy expiry date unfortunately on this occasion your application has been unsuccessful.
Eurofins is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.
Eurofins is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
