Quality Assurance Specialist

20 hours ago


Durham, North Carolina, United States MedPharm Full time
Job Description:

At MedPharm, we are seeking an experienced Quality Assurance Specialist to join our team. This is a critical role that requires expertise in validation protocols and regulatory compliance.

In this position, you will be responsible for collaborating with various teams to develop, execute, and report on qualification protocols. You will ensure that these protocols meet regulatory standards and maintain product integrity. Your key responsibilities will include:

• Developing cleaning procedures and processes for cGMP equipment in collaboration with manufacturing and packaging teams
• Reviewing Master Batch Records to assess the impact of chemicals and processes on the Cleaning Validation Program
• Creating protocols to validate secondary packaging equipment
• Maintaining temperature mapping and environmental chambers, ensuring compliance with regulatory requirements
• Commissioning equipment to support Drug Supply Chain Security Act (DSCSA) requirements
• Ensuring packaging designs and processes comply with FDA, GMP, and other regulatory requirements

Required qualifications for this role include:

• A Bachelor’s degree in a technical or life science field
• 5+ years of experience in validation within pharmaceutical manufacturing
• Expertise in packaging for semi-solid and liquid formulations
• Familiarity with regulatory requirements for pharmaceutical manufacturing (FDA, cGMPs, ISO, ICH guidelines)
• Excellent problem-solving skills and ability to work in a fast-paced environment

This is a challenging role that offers opportunities for growth and professional development. If you have a passion for quality assurance and a strong background in validation, we encourage you to apply.

Salary Estimate: $90,000 - $110,000 per year, depending on experience.

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