Senior Specialist II, Quality Assurance

Senior Specialist II, Quality Assurance (Blue Ash) A career at Resilience is more than just a job – it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. The Senior Specialist II, Quality Assurance (Blue Ash), is responsible for providing technical and operational quality oversight and support across inspection, assembly, packaging, incoming quality control, and product release activities. This role ensures compliance with cGMP, regulatory requirements, and internal quality standards through oversight of the inspection, assembly, and packaging of pharmaceuticals and combination products. This position requires a blend of strong technical expertise, quality assurance knowledge, and leadership capabilities to effectively collaborate across departments and lead initiatives that enhance product quality and process efficiency. Responsibilities include performing and overseeing production processes, sampling and testing activities, maintaining quality records and documentation; supporting technology and design transfers; troubleshooting quality-related issues, material and batch disposition, and providing guidance to cross-functional teams to ensure successful execution of quality objectives. This role requires advanced technical expertise, to be able to provide quality oversight of validation, investigations, change controls, and technology/design transfer. They may work independently or lead specialized projects, providing high-level strategic insight and technical advice. Responsibilities Provide quality oversight for complex and/or higher-level investigations, change controls, validation protocols, and technology transfer documents, ensuring adherence to established specifications, procedures, and regulatory requirements. Provide technical quality oversight, review, and approval of complex and higher-level validation documents including validation plans, requirement documents (URS, FS, SRA, SLIA, and ACA), protocols, data analysis, discrepancies, and final reports. Provide hands-on support and act as an SME and/or host during internal, regulatory, and customer audits and inspections. Provide quality oversight and approval for manufacturing, laboratory, and quality system activities, including batch disposition, material sampling and disposition, investigations, deviations, CAPAs, change controls, risk assessments, and validation activities. Ensure compliance with cGMP requirements and applicable regulatory standards through review of documentation, monitoring of quality systems, and support of inspection, assembly, packaging, testing, and release operations. Perform reviews and approvals of investigation initial impact assessments to determine the classification of deviations. Support of these investigations will also include; collaboration during root cause analyses sessions, resolution of product quality issues, and implementing effective corrective and preventive actions while driving continuous improvement initiatives. Serve as the Quality representative and subject matter expert for cross-functional projects, technology transfers, process improvements, audits, inspections, and regulatory interactions. Review, approve, and maintain quality documentation, records, procedures, specifications, validation documents, and quality metrics to ensure accuracy, completeness, and compliance. Support incoming material and component quality activities, including inspection, sampling, testing, and release decisions, while ensuring adherence to established quality standards. Partner with Manufacturing, Technical Operations, Supply Chain, and Quality teams to ensure consistent execution of quality systems, successful project delivery, and uninterrupted product flow. Provide technical guidance, training, and direction to technicians and team members, promoting compliance, operational excellence, and a culture of quality. Utilize quality and business systems (e.g., SAP, MAXIMO, CMMS, electronic quality management systems) to support documentation, inventory management, data analysis, metrics reporting, and quality decision-making. Collaborate with MSAT, Project Management, Engineering, and other departments to ensure seamless integration of new products and technologies into the manufacturing process. Assist in the review and approval of new product introductions, ensuring quality standards are met throughout the product lifecycle. Lead risk assessments (e.g. pFMEA) and implement strategies for mitigating technical and quality risks associated with manufacturing processes. Training and mentoring junior members of the QA organization and providing QA coaching to other non-QA employees within the area(s) supported. Minimum Qualifications Advanced technical expertise in the qualification of equipment, utilities, facilities, technology transfer, statistical analysis, investigation techniques, development, and risk management methodology and process validation, and/or Quality oversight in these disciplines. In-depth knowledge of current industry best practices and regulatory guidance expectations regarding technology transfer and validation, including the ability to interpret and apply that guidance to novel or ambiguous situations. Demonstrated ability to independently apply regulatory requirements to complex compliance decisions in a regulated environment (21 CFR 210, 211, 4, 820, ISO 13485, ISO 14971, EMA, PDA, ICH, etc.) Knowledge of Design Controls and demonstrated ability to lead change management for changes spanning multiple functions or sites Demonstrated leadership, relationship management, and organizational planning, including the ability to determine resources and timelines for quality deliverables that affect other functional areas, sites, or customers. Experience serving as a subject matter expert or host during customer audits and regulatory inspections, including presenting and defending quality decisions to inspectors. Experience leading risk assessments and applying risk management methodologies (e.g. Failure Modes and Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), Layers of Protection Analysis (LOPA), Preliminary Hazard Analysis (PHA), simple Lean tools, etc.). Expertise in quality management systems, including assisting with the design and implementation of new or improved QMS processes. Proven ability to solve complex problems requiring in-depth evaluation of technical, compliance, and business variables, and to work under pressure in a fast-paced environment. Strong interpersonal skills with the ability to lead cross-functional teams and influence without direct authority. Excellent written and verbal communication skills, including technical writing for documents and reports. Demonstrated ability to mentor and develop junior QA staff and provide technical coaching to non-QA partners in supported areas. Ability to travel approximately 5-10% based on project demand. Must have proficient computer skills and be experienced in Microsoft Office, including Word, Excel, PowerPoint, and Outlook. Preferred Qualifications Bachelor's degree or higher in Pharmaceutical Sciences, Chemistry, Engineering, Life Sciences, or related field. Minimum of 7 years of total combined experience in quality assurance and/or validation within a GMP regulated pharmaceutical and/or biotechnology manufacturing environment. Direct experience with GMP regulatory requirements relevant to pharmaceutical manufacturing. Proven track record in technical troubleshooting and root cause analysis. Prior cGMP inspection, medical device assembly, and/or packaging manufacturing experience. Experience within a multi-product facility. Experience with sterile manufacturing processes. Working knowledge of cGXP requirements for the manufacturing and inspection of pharmaceutical products. Previous experience in supporting regulatory inspections and audits. Work Schedule: 8 hours - Monday - Friday The work schedule listed reflects the employee's expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. This position may also include the following conditions: Sitting, Standing, Walking, Bending, Twisting, Reaching, Repetitive Motion, Noise Exposure, Chemical Usage, Monitoring other People's Work, and wearing Personal Protective Equipment (PPE). The items described here are representative of those that must be met successfully to perform the essential functions of this job. Sponsorship or support for work authorization, including visas, is not available for this position. Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process. Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, Resilience Corp.