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

Last updated : 2024-06-20