Senior Quality Specialist
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Job Location:
Lancaster, NE - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
- 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
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more
