Onsite GMP Change Control Lead for Analytical Sciences

Piper Companies; West Point (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

Piper Companies is seeking an Analytical Change Control Consultant to support a leading global pharmaceutical organization. You will own analytical Change Controls from initiation to closure, coordinating with scientists, SMEs, and Quality to ensure compliant documentation and timely implementation.

The role focuses on GMP-regulated environments, cross-functional teamwork, and driving continuous improvement in analytical methods and laboratory processes.

Qualifications

• Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• Experience in a GMP-regulated pharmaceutical/biotech environment.
• Strong laboratory, analytical sciences, quality or manufacturing support experience.
• Excellent communication and interpersonal skills for cross-functional collaboration.
• Highly organized with strong time management and multitasking abilities.
• Demonstrated ownership, analytical problem solving and task completion.
• Comfort with learning new systems and regulated processes.

Responsibilities

• Own and manage analytical Change Controls from initiation through final closure.
• Collaborate with change initiators to ensure complete documentation.
• Coordinate with laboratory scientists, technical SMEs, Quality, and stakeholders during the change process.
• Ensure impact assessments, documentation, and approvals meet internal procedures.
• Identify gaps, ask questions, and assess downstream impact of changes.
• Advance Change Controls by following up and maintaining momentum.
• Support changes to analytical methods, processes, new products, and CAPAs.

Skills

Communication

Time management

Ownership

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Tools

Veeva Vault

Job description

Piper Companies is seeking an Analytical Change Control Consultant to support a leading global pharmaceutical organization. You will own analytical Change Controls from initiation to closure, coordinating with scientists, SMEs, and Quality to ensure compliant documentation and timely implementation.

The role focuses on GMP-regulated environments, cross-functional teamwork, and driving continuous improvement in analytical methods and laboratory processes.