Senior QA Specialist - DSM Manufacturing & GMP Expert

Olon USA; Ohio; On-site; USD 100,000 - 150,000; Full time

Job summary

Olon USA is seeking a Senior Quality Assurance Specialist to drive QA oversight for DSM processes from development through commercial release. You will lead QA activities, assess changes, and ensure systems stay validated in a cGMP environment.

The ideal candidate has a BS in a technical field, 5+ years in GMP and FDA-regulated manufacturing, strong communication, and collaboration across global teams to meet schedules and regulatory expectations in Concord, OH.

Qualifications

• B.S. in Chemical Engineering, Chemistry or other technical disciplines.
• 5+ years of relevant chemical processing experience.
• 5+ years of experience in a GMP regulated environment.

Responsibilities

• Develop documents, processes, and procedures for the DSM program.
• Oversee change management to keep Manufacturing Systems validated and maintained through startup to commercial operation.
• Provide oversight and approval of lifecycle documentation, risk assessments, specifications, validation plans, and reports.
• Generate, review, and approve QA procedures for validation approaches and lifecycle documents.
• Generate, review, and approve QA documentation, procedures, and processes for operational readiness and QA support of manufacturing in a cGMP facility.
• Ensure project and operational quality objectives are met within timelines.
• Collaborate with other Olon sites to streamline processes and maximize efficiency.
• Participate in optimization initiatives and support regulatory inspections.
• Conduct quality meetings, oversee processing, review batch records, and perform other duties as assigned.

Skills

Verbal & written communication

English fluency

Time management

Critical thinking

Data integrity

cGMP & regulatory knowledge

Team collaboration

Problem solving

Education

B.S. in Chemical Engineering

B.S. in Chemistry

Job description

Olon USA is seeking a Senior Quality Assurance Specialist to drive QA oversight for DSM processes from development through commercial release. You will lead QA activities, assess changes, and ensure systems stay validated in a cGMP environment.

The ideal candidate has a BS in a technical field, 5+ years in GMP and FDA-regulated manufacturing, strong communication, and collaboration across global teams to meet schedules and regulatory expectations in Concord, OH.