- Applies GMP/GLP in all areas of responsibility, as appropriate
- Demonstrates and promotes the company vision
- Regular attendance and punctuality
- Applies the highest quality standard in all areas of responsibility
- 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
- Compliance - Stay current with client, regulatory, validation, IT, and e-record compliance regulations, and requirements. Ensure projects are completed in compliance with existing quality systems; Utilize independent judgement and experience to make quality based decisions.
- Provide support to implement new quality systems and programs. Provide support and input for client and/or regulatory audits
- Research - Assist with research of instrumentation with information obtained from vendors, manuals, and other resources to introduce new instruments. Integrate instrumentation into existing data center environments and workflows.
- Technical Writing - Author validation deliverables in accordance with established validation program. Develop and enhance software/instrumentation procedures.
- Training - Provide guidance and coaching within a team environment. Provide training to technical groups. Assist with developing training program and procedures.
- Validation Support - Accurately update validation program components. Perform evaluation of periodic review data for computerized systems. Provide oversight and/or perform e-record evaluations/remediation and provide guidance to technical groups
- Validation Testing - Assist with determining the approach to validate software and instrumentation. Utilize risk-based rationale to support approach. Provide quality project oversight and guidance to assist technical with testing. Review testing documentation generated by vendors, technical groups, and/or other validation team members. Summarize results and maintain documentation in an organized GXP compliant manner to demonstrate status.
- Conducts all activities in a safe and efficient manner
- Communicates effectively with client staff members Performs other duties as assigned
- Bachelors degree in physical science, engineering, or information technology
- 5 years of laboratory software and/or analytical instrumentation research, installation, programming, networking, and/or validation. Experience must include 2 years of authoring instrument validation deliverables (e.g. protocols, test scripts) within a GXP environment, A combination of college and related technical experience will be considered (e.g. 9+ years' experience)
- Strong knowledge of Windows OS, networking, and instrument PC connectivity and configuration (securities and file structure
- 5 years of experience with ELLI internal quality systems and procedures Quality/regulatory experience preferred
This position is full time Monday-Friday 9:00 am-5:00pm with overtime as needed.
Candidates currently living within a commutable distance of Lancaster Pennsylvania are encouraged to apply.
As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options.
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
