Job Description

This role supports the release and disposition of clinical supply materials for global clinical trials. The QA Operations Specialist ensures that products meet internal quality standards and regulatory requirements prior to release, and plays a key role in continuous improvement and operational excellence within a GMP-regulated environment.

Position: QA Operations Specialist – Clinical Supply Disposition

Location: Hybrid – Lansdale, Pennsylvania, (3 days onsite / 2 remote)

Term: Contract (2 year)

Schedule: Monday–Friday, standard business hours

Pay: 35-39/hr

Key Responsibilities:

• Evaluate and disposition clinical supply materials in accordance with company procedures, GMP regulations, and quality standards.
• Review batch records and associated documentation to ensure compliance with internal policies and external regulations.
• Support or coordinate the development and revision of procedures, quality processes, and continuous improvement initiatives.
• Assist in managing significant quality events, including root cause investigations and deviation support.
• Lead or contribute to performance improvement projects focused on reducing cycle times, improving yield, or enhancing efficiency.
• Apply Lean Six Sigma and MPS (Merck Production System) tools to both problem solving and routine operational activities.
• Collaborate cross-functionally with packaging, operations, quality, and supply chain teams.

Qualifications:

• Bachelor’s degree in Engineering, Science, or related field.
• 2+ years of experience in GMP-regulated pharmaceutical or related industry.
• Familiar with batch record review and disposition processes.
• Strong communication, problem-solving, and multitasking skills.
• Proficient in Microsoft Office (Excel, Outlook, Teams).
• Able to work independently and collaboratively in a team setting.
• Preferred: Experience with SAP, Veeva, QA/QC, and clinical packaging operations.

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

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