- 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 erecord 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 erecord evaluations/remediation and provide guidance to technical groups
- Validation Testing Assist with determining the approach to validate software and instrumentation. Utilize riskbased 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
Qualifications :
- 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
Additional Information :
This position is full time MondayFriday 9:00 am5:00pm 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 fulltime 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.
Remote Work :
No
Employment Type :
Fulltime