Job Description
The Senior Quality Assurance Specialist is responsible for helping to drive the Quality oversight for all Drug Substance Manufacturing (DSM) processes through to commercial release. This role is responsible for quality assurance oversight of day-to-day activities and resolution or mitigation of issues.
Olon USA is a contract manufacturing organization focused on making active pharmaceutical ingredients (API). The company is comprised of highly technical staff with about 75% of all employees being in a technical role. Significant interaction occurs between Chemical Engineers, Organic Chemists, and Analytical Chemists for each project that is executed.
What You’ll Do
- Performs a Subject Matter Expert role within the QA team for the development of documents, processes, and procedures for the DSM program.
- Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operation.
- Provides 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.
- Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems.
- Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in the cGMP regulated facility.
- Ensures project and operational quality objectives are met within desired timelines.
- Collaborates and aligns with other Olon sites to streamline processes and maximize efficiency.
- Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections.
- Conduct quality meetings, oversee execution of processing, participate on the floor as appropriate and review executed batch records.
- Performs other duties as assigned.
Knowledge, Skills, and Abilities
- Strong verbal and written communication skills to partner with different teams and stakeholders.
- Excellent oral and written communications skills and fluency in English. Italian is a plus.
- Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks.
- Ability to think critically and have superior problem-solving skills.
- High level of familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies.
- Understanding of Data Integrity, and application of 21 CFR Part 210, 211, and Part 11.
- Team based attitude and ability to build relationships and communicate effectively with others.
- Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
- Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.
Required Educational & Industrial Qualifications
- B.S. in Chemical Engineering, Chemistry or other technical disciplines.
- (5) or more years of relevant chemical processing experience is required.
- (5) or more years of experience working in a GMP regulated environment.
