GMP Data Review Group Leader – Analytical Sciences
Eurofins•Rensselaer, NY
•$29 - $35•Onsite
About The Position
We are seeking a GMP Data Review Group Leader – Analytical Sciences to support laboratory operations in a regulated environment. This role combines hands-on GMP data review with team leadership, ensuring the delivery of high-quality, compliant analytical data while developing a strong, accountable team. The ideal candidate brings cGMP expertise, a solid understanding of analytical techniques, and a proactive leadership approach focused on quality, efficiency, and continuous improvement.
Requirements
- Bachelor’s degree in Chemistry or related scientific field
- Minimum 2+ years of cGMP experience
- Minimum 2+ years of leadership experience
- Hands-on experience with HPLC/UPLC, UV-Vis, and chromatography data analysis
- Strong knowledge of GMP, GDP, and data integrity principles
- Excellent communication, organization, and attention to detail
- Ability to multitask in a fast-paced environment and work both independently and collaboratively
- Must be able to stand/walk for extended periods and lift up to 25 lbs
- Must be authorized to work in the U.S. without sponsorship
Nice To Haves
- Exposure to ELISA, MCE, or iCIEF preferred
Responsibilities
- Perform detailed review of GMP analytical data for accuracy, completeness, and procedural compliance
- Verify logbooks, notebooks, and electronic records for proper documentation practices (GDP)
- Ensure chain of custody is maintained and properly documented
- Review audit trails to confirm compliant execution and timing
- Partner with laboratory staff to investigate and resolve discrepancies, deviations, and corrections
- Conduct laboratory safety and compliance walkthroughs and document findings
- Maintain adherence to all required training, safety, and quality standards
- Lead, mentor, and develop a team of data reviewers
- Coordinate workload, ensuring timely and high-quality deliverables
- Support cross-training and team capacity planning
- Track and report on productivity, quality, and performance metrics
- Act as a key point of contact for clients and internal stakeholders
- Participate in hiring, onboarding, and training of new team members
- Deliver training programs and reinforce best practices in GMP data review
- Support scheduling needs, including overtime or weekend coverage as required
Benefits
- Comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
