Senior Specialist, Quality Assurance

RESILIENCE US INC • Hamilton, OH • 2d ago

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.
For more information, please visit www.resilience.com
Position Summary
This position is responsible for all QA activities that directly support execution of the process both within the Operations Teams and in assigned areas outside of Operations. These activities may include, but are not limited to, batch release, change control and documentation, SOPs, supplier management, distribution center management, and regulatory interactions.
Job Responsibilities
Maintain a high level of understanding of relevant production processes and quality systems.
Perform the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable:
Change Requests
Batch Records and associated documentation
Product and Component Release transactions in SAP
Quality Investigations (Deviations, Product Complaints)
Validation Plans, Protocols and Reports
Standard Operating Procedures
Accountable for disposition (release or rejection) of semi-finished and finished packaged product.
Collaborate with and influence other Quality professionals across the organization to ensure consistent application and execution of key quality systems.
Execute QA processes including batch record review, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectives.
Interface with applicable site support groups on projects (capital and non-capital) that impact the Operations/assigned area, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects
Collaborate with and influence other Operations/assigned area members to facilitate process improvements and risk assessments; benchmark internal and external QA practices to identify innovative efficient and effective practices.
Stay abreast of evolving regulatory compliance practices and recommend implementation strategies to site leaders
Collaborate in data analysis and report creation on quality metrics and key performance indicators
Strong collaboration between other areas to ensure consistent application of quality systems/processes across the site
Ability to work independently with minimal guidance from management
Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration
Demonstrate leadership capabilities
Train and mentor junior members of the QA organization and provide QA coaching to other non-QA employees within the area supported
Strong performance history of consistently meeting or exceeding expectations
Hold other accountable for high standards and clarify what needs to be accomplished, why, and the consequences for the individual and/or the organization
Demonstrate a strong understanding of the technology area to which the individual is aligned
Act as an execution lead/process owner for one or more processes
Minimum Qualifications
Prior experience in either the pharmaceutical industry, an operations environment, or Quality Assurance
Strong demonstrated knowledge of cGMPs, Quality Systems, and the pharmaceutical supply chain environment
Excellent oral and written communication skills
Strong ability and motivation to learn
Strong problem-solving skills
Ability to coach and mentor peers
Preferred Quali

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