Consultant - Quality Assurance Remediation Consultant (Hunt Valley, MD)

About the role

ProPharma is seeking up to 5 Quality Assurance Consultants for a 6 - 18 month engagement at their Hunt Valley, MD facility. The client has a backlog of 400 investigations and approximately 70-100 CAPA’s to address. The team consists of 100 QA personnel.

Responsibilities

• Provide oversight and guidance for quality assurance activities
• Conduct investigations related to contamination control
• Develop and implement corrective actions plans (CAPAs)
• Ensure compliance with regulatory standards and guidelines
• Support ongoing quality management systems improvements

Requirements

• Aseptic/contamination control background
• Experience with remediation
• Investigations experience

Qualifications

• Bachelor’s degree in a relevant field (e.g., Biomedical Engineering, Chemistry, Microbiology)
• Minimum 5 years of experience in quality assurance or related field
• Knowledge of industry regulations and standards (e.g., FDA, ISO)
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills

Skills

• Quality Management Systems (QMS) knowledge
• Regulatory affairs expertise
• Project management skills
• Technical writing and documentation skills

Benefits

ProPharma is an equal opportunity employer committed to diversity, equity, and inclusion. We offer a safe space for all employees to thrive and feel empowered. We do not use AI screening tools and all applications are personally reviewed by a member of our recruitment team. We encourage hybrid working arrangements for new hires based within a reasonable commute of our offices.

Pay

Compensation details are confidential and will be discussed during the interview process.

Schedule

The engagement is expected to last 6 - 18 months. The schedule may vary based on project needs.