Associate II, Quality Assurance (Night Shift)

Resilience•West Chester, OH

1d•$60,000 - $90,000•Onsite

About The Position

This position is responsible for all QA activities that directly support execution of the process both within the Inspection, Assembly, Packaging (IDAP) operations, and in assigned areas outside of IDAP. 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.

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 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 IDAP/assigned area, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects
Collaborate with and influence other IDAP/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