Associate II, Quality Assurance (Night Shift)

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 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

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 science is desirable
• Previous experience in a Lean, process-centric organization with an emphasis on continuous improvement
• Multi-site / multi-functional experience