Senior Quality Assurance Consultant
Job in
Dundalk, Baltimore City, Maryland, 21222, USA
Listed on 2026-08-04
Listing for:
United Pharma Technologies Inc
Full Time
position Listed on 2026-08-04
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Job Description & How to Apply Below
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.
- 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.
Position Requirements
10+ Years
work experience
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