Responsibilities include, but are not limited to, the following:Operate as part of a deviation’s management, change control and assay monitoring technical team. Investigate laboratory deviations and errors to determine root cause and ensure Corrective and Preventative Actions (CAPAs) are implemented by identifying root cause, identification and implementation of corrective and preventative actions, and authoring the final investigation report. Review data audits and author reports as needed. Ens... more details
Job Description
Responsibilities include, but are not limited to, the following:
Operate as part of a deviation’s management, change control and assay monitoring technical team.
Investigate laboratory deviations and errors to determine root cause and ensure Corrective and Preventative Actions (CAPAs) are implemented by identifying root cause, identification and implementation of corrective and preventative actions, and authoring the final investigation report
Review data audits and author reports as needed
Ensure investigations adhere to the compliance-driven timeline
Ensuring compliance in the laboratory in accordance with cGMPs, and GLPs, international regulations guidelines, and policies/procedures.
Qualification and Validation studies
Providing analytical change management support for Biochemistry, Chemistry, Virology, and Supplies Inspection testing labs (LOCV)
Technical oversight and execution of Biochemistry quality control assays
Support assay throughout the process including writing protocols, executing assay methods, and writing final reports
General lab duties (includes organizing supplies/media, removal of Biohazardous waste cleaning, stocking, cold room 5S, etc.)
Qualifications
The ideal candidate would possess:
Ability to learn quickly, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Attentiveness to detail
Experience with GMP documentation practices and a strong understanding of GMP practices in the instructions, and comply with company policies
Technical writing expertise
Root Cause Analysis expertise preferred
Project Management, Change Execution Management and Team Leadership experience in a Quality function
Demonstrated self-starter with capability to develop innovative solutions to challenges
Basic Minimum Qualifications:
BS degree in Biochemistry, Biology, Cell Biology or related discipline is preferred OR M.S. degree in life science, biochemistry, scientific discipline or engineering
3+ years in science industry experience
Experience Troubleshooting Laboratory Deviations
Experience in change controls
Experience in in execution of assay monitoring
Authorization to work in the United States indefinitely without restriction or sponsorship
Additional Information
Position is full-time, Monday - Friday 8:00am - 5:00 pm with overtime as needed. Candidates currently living within a commutable distance of West Point 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
Yearly goal-based bonus & eligibility for merit-based increases
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
Job Abstracts is an independent Job Search Engine. Job Abstracts is not an agent or representative and is not endorsed, sponsored or affiliated with any employer. Job Abstracts uses proprietary technology to keep the availability and accuracy of its job listings and their details. All trademarks, service marks, logos, domain names, and job descriptions are the property of their respective holder. Job Abstracts does not have its members apply for a job on the jobabstracts.com website. Additionally, Job Abstracts may provide a list of third-party job listings that may not be affiliated with any employer. Please make sure you understand and agree to the website's Terms & Conditions and Privacy Policies you are applying on as they may differ from ours and are not in our control.
We would like to take a second to Welcome You to Job Abstracts, the nation’s largest Pure Job Board. With over 3.1 million job listings from 15,000+ Companies & Organizations, we help job searchers find careers that match their interests. As an anonymous user, you have probably discovered how easy our system is to use. However, you have just scratched the surface of what we can offer.
We encourage you to Register so you can use our most powerful features: searching with multiple terms, setting up multiple locations, establishing favorite companies, and accessing your search history. If you find a job you like, you can apply directly for it, and then, keep notes on it. We will also keep a lookout for jobs that match your search terms and email you when we find something you may like.
You can register for free and the system is free to use. If you like our system so far, click on Register and unlock the power required by serious job searchers.
Any time you conduct a search, the system shows you job matches, ranked by their Relevance Score (RS).
The score is calculated by a proprietary algorithm that uses Intelligent Machine Learning.
The Relevance Score tells you how well the job opportunity matches your search term or terms.
When not logged in, the system is limited to one search term. Scores for single term matches are usually lower.
When you register, log in, and set up multiple terms prioritized by importance, the jobs found for you will receive a much higher Relevance Score.