Senior Quality Assurance Specialist

Olon USA • Concord, OH

1d

About The Position

The Senior Quality Assurance Specialist helps drive Quality oversight for Drug Substance Manufacturing (DSM) processes through commercial release. The role provides quality assurance oversight of day-to-day activities and the resolution or mitigation of issues. Olon USA is a contract manufacturing organization focused on making active pharmaceutical ingredients (API), with technical staff and close collaboration among Chemical Engineers, Organic Chemists, and Analytical Chemists on projects.

As a subject matter expert within the QA team, this role develops and oversees documents, processes, and procedures for the DSM program. It assesses the impact of system and process modifications and maintains oversight of change management to ensure manufacturing systems are validated before startup and remain in a validated state through commercial operation. The role also supports operational readiness and manufacturing operations in a cGMP-regulated facility, helps ensure quality objectives and timelines are met, collaborates with other Olon sites, contributes to improvement initiatives, and supports regulatory and third-party inspections.

Requirements

• Bachelor of Science degree in Chemical Engineering, Chemistry, or another technical discipline.
• At least 5 years of relevant chemical processing experience.
• At least 5 years of experience working in a GMP-regulated environment.
• Experience in validation, cGMP manufacturing operations, and/or quality oversight in an FDA-regulated facility.
• Strong verbal and written communication skills and fluency in English.
• Strong time management skills and ability to prioritize tasks and meet tight deadlines.
• Critical thinking and superior problem-solving skills.
• High familiarity with or understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing and IT systems, and related methodologies.
• Understanding of data integrity and application of 21 CFR Parts 210, 211, and 11.
• Team-based attitude, ability to build relationships, and effective communication with others.
• Collaborative attitude and willingness to work with global peers and cross-functional teams toward company and department goals.

Nice To Haves

• Italian language skills.

Responsibilities

• Serve as a subject matter expert within the QA team for developing DSM program documents, processes, and procedures.
• Assess the impact of system and process modifications and oversee change management processes to ensure manufacturing systems are validated and maintained in a validated state through startup and commercial operation.
• Provide oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process, and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
• Generate, review, and approve QA procedures for the validation approach and lifecycle documents for manufacturing systems.
• Generate, review, and approve QA documentation, procedures, and processes for operational readiness and QA support of manufacturing operations in a cGMP-regulated facility.
• Ensure project and operational quality objectives are met within desired timelines.
• Collaborate and align with other Olon sites to streamline processes and maximize efficiency.
• Participate in optimization and improvement initiatives and support regulatory agency and third-party inspections.
• Conduct quality meetings, oversee processing execution, participate on the floor as appropriate, and review executed batch records.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior