Senior Quality Engineer - NPI & Tech Transfer

APHENA PHARMA SOLUTIONS-MARYLAND LLC; Easton (MD); On-site; USD 85,000 - 125,000; Full time

Job summary

APHENA PHARMA SOLUTIONS-MARYLAND LLC seeks a Quality Engineer to oversee and support all phases of the product quality lifecycle as we transfer products into commercial operations. You will drive tech transfer with cross-functional teams and ensure on-spec production and continual improvement.

The role includes collaborating with site leadership to analyze incoming materials, drive CAPA, and maintain quality documentation to support manufacturing and packaging operations.

Qualifications

• 5+ years in an FDA-regulated industry (medical device/pharma).
• Experience with root-cause analysis and CAPA processes.
• Strong technical writing and data analysis skills.

Responsibilities

• Drive tech transfer activities across the product lifecycle.
• Support quality operations during commercialization and scale-up.
• Trend quality data and investigate deviations/complaints.
• Prepare and review MSA, Control Plans and related docs.
• Collaborate with suppliers and cross-functional teams to ensure compliance.

Skills

Quality engineering

Root cause analysis

Data analysis

MS Office

Statistical software

Cross-functional collaboration

Education

Bachelor's degree in engineering or related science

Tools

ERP systems

eQMS

Documentation tools

Job description

APHENA PHARMA SOLUTIONS-MARYLAND LLC seeks a Quality Engineer to oversee and support all phases of the product quality lifecycle as we transfer products into commercial operations. You will drive tech transfer with cross-functional teams and ensure on-spec production and continual improvement.

The role includes collaborating with site leadership to analyze incoming materials, drive CAPA, and maintain quality documentation to support manufacturing and packaging operations.