Senior Quality Systems Specialist: CAPA & Change Control

Catalent; Harmans (MD); On-site; USD 105,000 - 120,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Paid time off

8 holidays

Tuition reimbursement

Career growth

Job summary

Catalent's Harmans, MD facility seeks a Senior Specialist, Quality Systems to support CAPA, deviation management, investigations, and change control within GMP manufacturing of biologics. You will compile and trend quality metrics and ensure regulatory compliance.

This onsite role emphasizes data-driven quality improvements, audit readiness, and training across QA/QC teams. 8am–4:30pm shift, Harmans, MD.

Qualifications

• Master’s degree with 2–4 years QA experience in biologic/pharma/medical device industries.
• OR Bachelor’s degree with 4–6 years QA experience in the same fields.
• Experience with GMPs and 21 CFR Parts 210/211 or QSR Part 820.

Responsibilities

• Administer CAPA, deviation, investigation, and change control processes.
• Author and maintain quality records including deviations, investigations, CAPAs, change controls, and GMP SOPs.
• Track, trend, and analyze Quality System metrics with routine management reports.
• Conduct CAPA and change effectiveness evaluations using data.
• Maintain Quality System tracking tools and reporting mechanisms.
• Monitor compliance activities and identify improvement opportunities.
• Support audits and cross‑functional quality initiatives.
• Deliver Quality Systems training and manage user access.

Skills

Quality Assurance

CAPA

Deviation management

Change control

Quality metrics

Regulatory compliance

GMP

Biotech industry

Education

Master's degree in Scientific/Engineering/Biotech

Bachelor's degree in Scientific/Engineering/Biotech

Tools

Microsoft Excel

PowerPoint

Access

Teams

SharePoint

Job description

Catalent's Harmans, MD facility seeks a Senior Specialist, Quality Systems to support CAPA, deviation management, investigations, and change control within GMP manufacturing of biologics. You will compile and trend quality metrics and ensure regulatory compliance.

This onsite role emphasizes data-driven quality improvements, audit readiness, and training across QA/QC teams. 8am–4:30pm shift, Harmans, MD.