GMP Data Review Group Leader Analytical Sciences

GMP Data Review Group Leader Analytical Sciences

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.

Key Responsibilities

Data Review & Compliance

• 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

Leadership & Team Management

• 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

Qualifications

• Bachelor's degree in Chemistry or related scientific field
• Minimum 2+ years of cGMP experience and 2+ years of leadership experience
• Hands-on experience with HPLC/UPLC, UV-Vis, and chromatography data analysis
• Exposure to ELISA, MCE, or iCIEF preferred
• 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

Additional Information

• 10-15 Minute Phone Interview with Region Recruiter
• 45-60 Minute Virtual Interview with Manager and/or Group Leader
• 30 Minute Virtual Interview with Site Director

This is a full-time, 100% onsite position based on a first-shift schedule (MondayFriday, 8:30am4:30pm), with overtime required as needed. Candidates located within a commutable distance to Rensselaer, New York, are strongly encouraged to apply.

Excellent full-time benefits include:

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Hourly rate is between $28.50 - $34.75 depending on education and experience