Ensures quality control and quality assurance compliance across the manufacturing site. Serves as an integral member of site leadership team with a focus on ensuring quality system requirements are achieved. Leads the site quality control unit and serves as the primary backup to the QA Site Director.

Responsibilities

• Manages the Quality Control (QC) laboratory including direct reports and budgetary responsibilities
• Member of the Laboratory Center of Excellence (COE)
• Serves as the standalone laboratory systems and site Maximo administrator
• Reviews and approves raw materials and commodities including ERP approval
• Exception Report (ER) investigation, writing, review, and approval including ensuring effective CAPAs
• Qualification and validation protocol writing, review, and approval
• Actively participates in Periodic Validation Reviews, Annual Product Reviews, internal audits, and process data reviews
• Provides front room and laboratory SME support during regulatory agency and internal inspections
• Manages change related to compendia, supplier/service provider notifications, material specifications, analytical test methods, test method validation, SOPs, batch records, and site service requests
• Leads the implementation of Quality-related projects including metrics

Significant Work Activities: 

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Continuous walking for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Frequent to continuous computer usage (greater or equal to 50% of the workday) is required