Deviation Management Consultant

Piper Companies is seeking a Deviations Management Consultant to support a multinational pharmaceutical/vaccine manufacturer in Durham, NC.

Responsibilities:

• Provide technical support to project team, ensuring compliance with cGMP, GLPs, CFRs, and international regulations
• Perform data integrity within biochemistry laboratories and drug manufacturing spaces by leading investigations via root cause analysis
• Focus on Endotoxin assays and elevate compliance, assay robustness, and lab performance
• Drive process improvements, execute timely projects, and complete technical documentation

Qualifications:

• 2+ years of experience leading major investigations on deviations in a highly regulated pharmaceutical manufacturing (GMP) environment
• Highly proficient in technical writing, protocol development, and documentation
• A biochemistry background with assay experience and analytical chemistry skills including HPLC, UV, wet chem, compendial testing, and ICP analysis is a plus
• Knowledge of method validation and equipment qualification
• Bachelor's/Master's degree in Chemistry or related field

Compensation includes:

• Salary Range: $35-40 / hour
• Benefits: Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays

This job opens for applications on 03/17/2025.

Applications for this job will be accepted for at least 30 days from the posting date.

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