Job Description

GMP Data & Documentation Review

• Review GMP data generated by testing personnel to ensure compliance with governing procedures
• Verify logbook entries for completeness, accuracy, and adherence to GDP standards
• Confirm sample chain of custody integrity throughout testing activities
• Review audit trails to ensure actions executed align with procedural requirements and timelines

Communication & Issue Resolution

• Communicate clearly and efficiently with testing personnel to resolve annotations, discrepancies, or corrections
• Partner with laboratory staff to support compliance and continuous improvement

Good Documentation Practices (GDP)

• Accurately document activities in logbooks, laboratory notebooks, and electronic systems using GDP principles

Safety & Compliance

• Conduct laboratory safety and compliance walkthroughs, documenting observations as required
• Complete all required safety, procedural, and refresher trainings on time

Qualifications

Education & Experience

• Bachelor’s degree (BS) in Chemistry, Life Sciences, or a related scientific discipline
• 1–2 years of cGMP experience in a regulated laboratory environment

Technical Skills

• Hands-on experience with HPLC/UPLC and UV‑Vis spectrophotometry
• Experience with ELISA, MCE, and/or iCIEF techniques preferred
• Proficiency in processing and reviewing quantitative liquid chromatography data

Professional Skills

• Strong computer literacy and organizational abilities
• Excellent written and verbal communication skills with high attention to detail
• Demonstrated integrity, professionalism, and strong work ethic

Work Style & Physical Requirements

• Ability to work independently as well as collaboratively within a team
• Self‑motivated, adaptable, and maintains a positive attitude in a fast‑paced environment
• Capable of meeting physical demands, including lifting 25 lbs. or more, prolonged standing or walking, pushing/pulling carts or equipment, and bending or reaching for supplies

Additional Requirements

• Ability to learn new processes, manage multiple tasks simultaneously, and maintain accurate records
• Ability to follow instructions and comply with company policies and regulatory requirements
• Authorized to work in the United States indefinitely without restriction or sponsorship

Additional Information

• Position is Monday- Friday, 8:30 AM -4:30 PM. Overtime as needed.
• Pay range: $22.50 - $23.50/hour
• 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

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.