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 :

• Bachelors 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 :

What to Expect in the Hiring Process: 

• 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 

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

Remote Work :

No

Employment Type :

Full-time