Senior Quality Assurance Consultant

United Pharma Technologies Inc; Maryland; On-site; USD 90,000 - 150,000; Full time

Job summary

Our client in Hunt Valley, MD seeks experienced Quality Assurance Consultants to support a large remediation initiative. The onsite role targets backlogged investigations and CAPAs while strengthening contamination control in a sterile manufacturing environment.

The ideal candidate has 7+ years of QA experience in regulated medical device or pharmaceutical manufacturing, with hands-on aseptic processing, CAPA, and remediation expertise.

Qualifications

• 8+ years of Quality Assurance experience in Medical Device or Pharmaceutical manufacturing.
• Hands-on experience with aseptic manufacturing and contamination control.
• Strong background in deviation investigations, CAPA, and quality system remediation.
• Experience with environmental monitoring, cleanroom controls, and sterile manufacturing.
• Knowledge of disinfectant efficacy studies, airflow/smoke studies, and contamination risk assessments.
• Experience developing and implementing quality procedures and remediation plans.
• Must be available to work onsite in Hunt Valley, MD for the duration of the engagement.
• Previous FDA remediation or compliance improvement experience is highly preferred.

Responsibilities

• Lead and support deviation investigations and CAPA activities.
• Execute quality system remediation initiatives and verify remediation effectiveness.
• Develop and implement contamination control strategies.
• Support sterile manufacturing and aseptic processing operations.
• Review environmental monitoring data and cleanroom control programs.
• Perform contamination risk assessments for facilities and utilities.
• Support disinfectant efficacy studies, airflow analysis, and smoke study assessments.
• Develop, revise, and implement SOPs and quality procedures.
• Collaborate with cross-functional teams to drive compliance with FDA and GMP requirements.

Skills

Quality Assurance

Aseptic processing

CAPA investigations

Deviation investigations

Regulatory compliance

Environmental monitoring

Job description

Our client, a leading Medical Device manufacturer, is seeking experienced Quality Assurance Consultants to support a large-scale quality remediation initiative at their Hunt Valley, MD facility. This onsite role will focus on reducing a backlog of approximately 400 investigations and 70-100 CAPAs, while strengthening contamination control and quality system compliance within a sterile manufacturing environment.

The ideal candidate will have 7+ years of Quality Assurance experience in regulated medical device or pharmaceutical manufacturing, with strong expertise in aseptic processing, investigations, CAPA, and remediation activities.

Key Responsibilities

• Lead and support deviation investigations and CAPA activities.
• Execute quality system remediation initiatives and verify remediation effectiveness.
• Develop and implement contamination control strategies.
• Support sterile manufacturing and aseptic processing operations.
• Review environmental monitoring data and cleanroom control programs.
• Perform contamination risk assessments for facilities and utilities.
• Support disinfectant efficacy studies, airflow analysis, and smoke study assessments.
• Develop, revise, and implement SOPs and quality procedures.
• Collaborate with cross-functional teams to drive compliance with FDA and GMP requirements.

Required Qualifications

• 8+ years of Quality Assurance experience in Medical Device or Pharmaceutical manufacturing.
• Hands-on experience with aseptic manufacturing and contamination control.
• Strong background in deviation investigations, CAPA, and quality system remediation.
• Experience with environmental monitoring, cleanroom controls, and sterile manufacturing.
• Knowledge of disinfectant efficacy studies, airflow/smoke studies, and contamination risk assessments.
• Experience developing and implementing quality procedures and remediation plans.
• Must be available to work onsite in Hunt Valley, MD for the duration of the engagement.
• Previous FDA remediation or compliance improvement experience is highly preferred.