Quality Assurance Engineer, Drug Substance (DSM) Validation

Olon Ricerca Bioscience Llc; Concord (OH); Sur place; USD 80 000 - 110 000; Plein temps

Résumé du poste

Olon Ricerca Bioscience Llc in Concord, OH seeks a Quality Engineer to drive QA oversight for Drug Substance Manufacturing (DSM) processes through commercial release. The role ensures validation, change management, and documentation oversight in a cGMP facility.

Key responsibilities include developing QA documents, risk assessments, validation plans, and batch record reviews, while collaborating with global peers to meet timelines and regulatory expectations.

Qualifications

• Excellent verbal and written communication in English; Italian is a plus.
• Strong time management and ability to meet deadlines.
• Experience in validation of production equipment and quality systems.
• Understanding of Data Integrity and 21 CFR Part 210/211/11.
• Team-based attitude and cross-functional collaboration.
• GMP/regulatory environment experience.

Responsabilités

• Performs SME role within QA for DSM development documents, processes and procedures.
• Oversees change management and validation status from startup to commercial operation.
• Approves lifecycle documentation, risk assessments, specs, and validation reports.
• Generates and approves QA procedures and validation lifecycle documents.
• Supports manufacturing operations QA in cGMP facilities and ensures timely objectives.
• Collaborates with Olon sites to streamline processes and improve efficiency.
• Participates in regulatory inspections and internal improvement initiatives.
• Leads quality meetings and reviews batch records.

Connaissances

Communication skills

English fluency

Time management

Critical thinking

Problem solving

Validation knowledge

Data integrity

Team collaboration

Cross-functional collaboration

Formation

B.S. in Chemical Engineering

B.S. in Chemistry

Description du poste

Olon Ricerca Bioscience Llc in Concord, OH seeks a Quality Engineer to drive QA oversight for Drug Substance Manufacturing (DSM) processes through commercial release. The role ensures validation, change management, and documentation oversight in a cGMP facility.

Key responsibilities include developing QA documents, risk assessments, validation plans, and batch record reviews, while collaborating with global peers to meet timelines and regulatory expectations.