Associate II, 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 Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions.
At this level the incumbent is not necessarily performing all the essential job functions of the role immediately. The incumbent may begin by specializing in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs. Over time the incumbent will be expected to obtain the necessary training to become skilled in all major responsibilities of the role.
This is a Night Shift (12-Hour Rotating, 2/2/3 Schedule)
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
Collaborate with and influences 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 PET/assigned area, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects
Collaborate with and influence other PET/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
Minimum Qualifications
Experience in either the pharmaceutical industry, an operations environment, or Quality Assurance
Excellent oral and written communication skills
Strong ability and motivation to learn
Preferred Qualifications
Bachelor's degree; master's degree in quality assurance/regulatory affairs is desirable
Previous experience in a Lean, process-centric organization with emphasis on continuous improvement
Multi-site / multi-functional experience
Considerable experience in Quality Assurance
This position may also include the following: Performing AQL testing and this is subject to passing AQL qualifications and passing an eye exams.
The items described here are representative of those that must be met successfully to perform the essential functions of this job.
Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consider

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