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.
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