Senior Quality Assurance Specialist - 2nd shift!

Job Description

Job DescriptionCompany Description

Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialized clinical diagnostics testing.

Job Description

Essential Duties and Responsibilities:

 Applies GMP/GLP in all areas of responsibility, as appropriate

 Applies the highest quality standard in all areas of responsibility

 Demonstrates and promotes the company vision

 Regular attendance and punctuality

 Demonstrates strong client service skills, teamwork, and collaboration

 Proactively plans and multitasks to maximize productivity

 Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration

 Use opportunities to contribute to continuous quality and process improvement of QA department and of the laboratories

 Demonstrate understanding of QAU operations and functions

 Perform investigation writing and review including thorough root cause analysis and CAPA

 Perform internal audits and walk through inspections

 Review procedures, methods and protocols

 Release analytical reports

 Host client audits, appropriately respond to findings and recommendations

 Provide information/entries for monthly/quarterly quality reports to management

 Conducts all activities in a safe and efficient manner

 Communicates effectively with clients and staff members

 Take initiative to diagnose problems, solve simple problems, and present suggestions for solutions to complex problems

 Review client or agency documents and identify requirements outside our usual practices, communicate to technical operations, assist with implementing appropriate changes

 Keep abreast of regulatory or industry quality assurance (QA) requirements, consult with clients or regulatory authorities regarding any special QA requirements they may have, assist technical operations with application and interpretation of regulations

 Assist and/or prepare and present training programs as needed to satisfy regulatory requirements

 Serve as mentor to specialists to successfully complete assignments

 Identify and drive process improvements, both within the department and for laboratory operations; determine the most effective way to accomplish a goal or strategy; suggest improvements to maximize quality and productivity while remaining compliant.

 Demonstrate skill in using the computer to access information, perform job functions (e.g., spreadsheets, power point), and prepare documents

Qualifications

To perform this job successfully, the individual must be able to independently perform the following requirements below:

• Investigation writing and review, including thorough root cause analysis Technical writing and review
• Tracking action items and driving to completion
• Ability to identify trends in recurring events
• Work with the laboratory and support groups to improve quality metrics, and enable CAPA implementation
• Internal audits support Review/write QAU procedures.
• Preferred Microbiology background

Basic Minimum Qualifications:

• Bachelor's degree in Biology, Microbiology or related science field
• Strong computer skills including word processing, spreadsheets, powerpoint and databases is preferred
• Experience in GMP environment is preferred

Additional Information

Position is Full-Time, Monday-Friday, 2nd shift, with additional hours, as needed. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply.

What we Offer:

• 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

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Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.