Resilience

Associate II, Quality Assurance (Night Shift)

USA - OH - West Chester · Mid

Work authorization required$60k-$90kDetected 28 days ago

Data AnalysisComplianceSAPGMPCommunication

About the role

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.
Over time the incumbent will be expected to obtain the necessary training to become skilled in all major responsibilities of the role.

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.
Maintain a high level of understanding of relevant production processes and quality systems
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
Collaborate in data analysis and report creation on quality metrics and key performance indicators

Experience in either the pharmaceutical industry, an operations environment, or Quality Assurance

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
The work schedule listed reflects the employee's expected schedule at the time of hire.
The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations.
Resilience is an Equal Employment Opportunity Employer.
Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healt

Sponsorship or support for work authorization, including visas, is not available for this position.

This listing is sourced directly from Resilience's careers page and normalized into a canonical job model.