Pharma Quality Engineering & Compliance Specialist

ARx Recruitment Solutions; Pennsylvania; On-site; USD 65,000 - 90,000; Full time

Job summary

ARx Recruitment Solutions seeks a Quality Engineering Support Specialist in Glen Rock, PA, US to provide quality engineering support for raw materials and supplier qualification. You will collaborate with crossfunctional teams to improve processes, products, and packaging operations in a regulated pharmaceutical environment.

The role emphasizes applying risk-based methods, data analysis, audits, and regulatory compliance, with a focus on continuous improvement and robust GMP practices within

Qualifications

• Bachelor’s degree in Engineering (Chemical preferred) or related technical field.
• Minimum 2 years of experience in pharmaceutical manufacturing or regulated cGMP environment.
• Knowledge of cGMP, FDA protocols, cleaning and process validation; familiarity with DOE/QBD/PAT/LEAN.

Responsibilities

• Assist in developing quality systems related processes with cross-functional teams.
• Lead execution of development and validation protocols in packaging areas per 21 CFR 211.
• Support raw material and supplier qualification, including documentation review.
• Perform internal/external audits and supplier scorecards.
• Coordinate quality sampling, in-process inspections, and deviations investigations.
• Contribute to change control activities and risk-based quality decisions.
• Maintain reports, SOPs, and controlled documents for quality activities.
• Provide technical oversight during development, scale-up, and validation trials.

Skills

Quality engineering

Regulatory compliance

Quality assurance

Audits

Education

Bachelor’s degree in Engineering (Chemical preferred)

Tools

Excel

Word

PowerPoint

Outlook

Job description

ARx Recruitment Solutions seeks a Quality Engineering Support Specialist in Glen Rock, PA, US to provide quality engineering support for raw materials and supplier qualification. You will collaborate with crossfunctional teams to improve processes, products, and packaging operations in a regulated pharmaceutical environment.

The role emphasizes applying risk-based methods, data analysis, audits, and regulatory compliance, with a focus on continuous improvement and robust GMP practices within