Quality Specialist II

Germer International - Pharmaceutical Recruiting; Malvern (Chester County); On-site; USD 70,000 - 95,000; Full time

Job summary

Germer International - Pharmaceutical Recruiting is seeking a QA Specialist II to support production from a quality perspective, ensuring targets are met with high quality and compliance. You will perform on-floor QA, handle deviations, investigations, batch documentation, and release certificates, collaborating across functions to deliver timely results.

The role requires a Bachelor's degree and 2+ years in pharma/biopharma, with 1–2 years in quality preferred, and offers exposure to audit

Qualifications

• Bachelor’s degree in a commercial or scientific field.
• 2+ years in Pharmaceutical/Biopharmaceutical industry.
• 1–2 years in a Quality role preferred.

Responsibilities

• Support on-floor QA procedures.
• Provide QA input for deviations, investigations, and audits.
• Communicate with cross-functional teams to ensure timely QA reviews and dispositions.
• Compile batch documentation and generate release certificates.
• Review data to identify trends or issues.
• Support development of quality systems.
• Complete line clearance and changeover activities for product campaigns.
• Oversee aseptic process qualifications (APS) and vial inspections.
• Review environmental monitoring data to support changeovers.

Skills

On-floor QA

Quality systems

Data trend analysis

Cross-functional comms

Documentation control

Audit readiness

Education

Bachelor's degree

Job description

The QA Specialist II supports all business operations from a Quality perspective, providing oversight, strategic thinking, and results focus to reliably meet and/or exceed the site’s production targets while achieving high levels of quality. The individual is capable of partnering across the organization to manage a fast-paced production environment and deliver exceptional service to our clients. The individual also ensures business, quality and compliance goals are met in full compliance with all government-issued environmental, health, safety, quality, and regulatory policies and guidelines.

Responsibilities:

• Support on the floor activities through shop floor QA procedures.
• Provide Quality input and guidance for deviations and laboratory investigations, technical documentation, program/process optimization projects, and audit readiness initiatives.
• Communicate effectively with cross functional departments to ensure on time delivery of QA review and disposition responsibilities.
• Compile batch and testing documentation and generate certificates for release of testing and manufacturing batches within assigned timelines to effectively deliver results to client.
• Ability to review data and effectively identify trends or key issues.
• Support the development of quality systems
• Complete line clearance and changeover activities to support product campaigns.
• Print master batch records
• Oversee Aseptic process qualifications (APS) and vial inspections for APS and Drug product.
• Review environmental monitoring (EM) data to support changeover of suites as well as in process EM.

Education, Experience, and Qualifications:

• Bachelor’s degree in a commercial or scientific field required.
• Minimum of 2 years experience within Pharmaceutical/Biopharmaceutical industry.
• 1-2 years in a Quality role within Pharmaceutical/Biopharmaceutical industry is preferred.