Pharma Quality Engineering & Compliance Specialist

Adhesives Research, Inc.; Glen Rock (York County); On-site; USD 75,000 - 110,000; Full time

Job summary

Adhesives Research, Inc. is seeking a Quality Engineering Support Specialist to provide quality engineering support for raw materials, supplier qualification, and packaging operations in Glen Rock, PA.

The role partners with cross-functional teams to ensure compliant processes, investigate issues, and drive continuous improvement. The ideal candidate has a Bachelor’s degree in a technical field, 2+ years in pharmaceutical/regulated manufacturing, and strong skills in cGMP, DOE, statistics, and

Qualifications

• Requires Bachelor’s degree in an Engineering (Chemical preferred), Pharmaceutical Sciences or other Technical discipline.
• Two (2) years minimum experience in pharmaceutical manufacturing, quality, engineering, or regulated cGMP manufacturing environment.
• Training and/or experience in cGMP and FDA protocols, cleaning validation and process validation; preferably also experience in design control, DOE, statistical analysis, QBD, PAT, Risk Analysis and LEAN manufacturing.
• Strong attention to detail and ability to make sound, risk-based quality decisions.

Responsibilities

• Assists in developing modified and new processes for quality systems related to producing specialized drug delivery therapeutic products.
• Performs a variety of engineering tasks, including review of developmental and validation protocols and leads execution in packaging areas in compliance with 21CFR 211.
• Provides quality engineering support for raw material and supplier qualification processes.
• Performs internal and external audits as applicable.
• Collaborates with Supply Chain, Purchasing, Quality Assurance, and Manufacturing.

Skills

Attention to detail

cGMP training

DOE

Statistical analysis

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Pharmaceutical Sciences

Tools

Excel

Word

PowerPoint

Outlook

Statistical software

Job description

Adhesives Research, Inc. is seeking a Quality Engineering Support Specialist to provide quality engineering support for raw materials, supplier qualification, and packaging operations in Glen Rock, PA.

The role partners with cross-functional teams to ensure compliant processes, investigate issues, and drive continuous improvement. The ideal candidate has a Bachelor’s degree in a technical field, 2+ years in pharmaceutical/regulated manufacturing, and strong skills in cGMP, DOE, statistics, and