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Resilience · 9 hours ago

Associate II, Quality Assurance (Night Shift)

West Chester, OH

Full-time

Onsite

New Grad, Entry Level

$60K/yr - $90K/yr

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. The Associate II, Quality Assurance position is responsible for all QA activities supporting process execution, including batch release, change control, and documentation, while also collaborating with other quality professionals to ensure compliance and process improvements.

BiopharmaBiotechnologyHealth CareLife SciencePharmaceutical

No H1B

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