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Analytical Change Control Consultant

Piper Companies

Analytical Change Control Consultant Location: West Point, PA (100% Onsite, Monday–Friday) Schedule: Mon - Fri Onsite Duration: 12-Month Contract (Potential Extension) Industry: Pharmaceutical / Life Sciences Piper Companies is seeking an Analytical Change Control Specialist to support a leading global pharmaceutical organization within its Analytical Sciences group. This role is ideal for someone with a strong laboratory or analytical sciences background who enjoys collaborating across functions, driving projects to completion, and ensuring quality and compliance in a GMP-regulated environment. As the Change Owner, you will coordinate analytical change requests from initiation through closure, partnering with scientists, technical subject matter experts, and cross-functional stakeholders to ensure changes are accurately documented, appropriately assessed, and successfully implemented. Responsibilities Own and manage analytical Change Controls from initiation through final closure. Partner with change initiators to understand proposed changes and ensure complete and accurate documentation. Coordinate with laboratory scientists, technical SMEs, Quality, and other stakeholders throughout the change process. Ensure impact assessments, supporting documentation, and required approvals are completed in accordance with internal procedures. Proactively identify gaps, ask thoughtful questions, and evaluate the downstream impact of proposed changes. Drive Change Controls forward by following up on outstanding actions and maintaining project momentum. Support changes related to analytical methods, laboratory processes, new product introductions, assay improvements, CAPAs, deviations, and continuous improvement initiatives. Build strong working relationships across multiple departments while communicating effectively with stakeholders at all organizational levels. Maintain compliance with GMP requirements and internal quality systems. Required Qualifications Bachelor's degree in Biology, Microbiology, Chemistry, Biochemistry, Pharmaceutical Sciences, or another related scientific discipline. Experience working in a GMP-regulated pharmaceutical or biotechnology environment . Strong laboratory, analytical sciences, quality, or manufacturing support experience. Excellent communication and interpersonal skills with the confidence to engage cross-functional stakeholders. Highly organized with strong time management and the ability to manage multiple priorities simultaneously. Demonstrated ability to take ownership of work, solve problems analytically, and drive tasks through completion.l> Comfortable learning new systems and navigating regulated processes. Preferred Qualifications Experience with Change Control, Change Management, or Quality Systems. Analytical Sciences or laboratory operations experience. Experience supporting analytical testing, assay development, assay transfers, or method changes. Knowledge of CAPAs, deviations, investigations, or continuous improvement initiatives. Experience with compendial testing, microbiology, bioburden, USP testing, or other analytical laboratory functions.li> Project management or cross-functional project coordination experience. Experience with Veeva Vault or other electronic Quality Management Systems (eQMS) is a plus. Ideal Candidate The ideal candidate is a proactive, scientifically minded professional who enjoys understanding how processes work and identifying opportunities to improve them. You ask thoughtful questions, communicate effectively with a variety of stakeholders, and are comfortable taking ownership of complex work from start to finish. Whether you've formally managed Change Controls or have supported laboratory process improvements, method implementations, or quality initiatives, you'll thrive in this collaborative and highly visible role. Compensation: Pay Rate: Commensurate to experience Benefits Available: Medical, Dental, Vision, Sick Leave as required by law, and PTO This job opens for applications on 8/6/2026 . Applications for this job will be accepted for at least 30 days from the posting date.

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Vacancy posted 2 days ago
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