Associate II, Quality Assurance (Night Shift)

Resilience•West Chester, OH

1d•$60,000 - $90,000•Onsite

About The Position

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.

Requirements

Experience in either the pharmaceutical industry, an operations environment, or Quality Assurance
Excellent oral and written communication skills
Strong ability and motivation to learn

Nice To Haves

Bachelor’s degree; master’s degree in science is desirable
Previous experience in a Lean, process-centric organization with an emphasis on continuous improvement
Multi-site / multi-functional experience

Responsibilities

Maintain a high level of understanding of relevant production processes and quality systems
Perform the QA review and approval of GMP documentation including Change Requests, Batch Records, Product and Component Release transactions in SAP, Quality Investigations (Deviations, Product Complaints), Validation Plans, Protocols and Reports, and 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.
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.