Senior Quality Assurance Specialist

Olon USA LLC•Concord Township, OH

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 supports the resolution or mitigation of issues. Olon USA is a contract manufacturing organization focused on producing active pharmaceutical ingredients (API), with technical staff and collaboration among Chemical Engineers, Organic Chemists, and Analytical Chemists.

Requirements

B.S. 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 to partner with different teams and stakeholders.
Fluency in English and excellent oral and written communication skills.
Strong time-management skills and ability to meet tight deadlines and prioritize tasks effectively.
Critical-thinking ability 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 Part 210, Part 211, and Part 11.
Team-based attitude, ability to build relationships and communicate effectively, and willingness to work collaboratively 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 documents, processes, and procedures for the DSM program.
Assess the impact of system and process modifications and oversee change management to ensure Manufacturing Systems are validated and maintained in a validated state through startup and commercial operation.
Oversee and approve 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 objectives and QA support of manufacturing operations in a cGMP-regulated facility.
Ensure project and operational quality objectives are met within desired timelines.
Collaborate with other Olon sites to streamline processes and maximize efficiency.
Participate in optimization or 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.