Manager, Quality Control Laboratory

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
• Bachelor's degree with 10 years of pharmaceutical Quality experience (preferably in QC) or an equivalent combination of education and experience
• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.
• AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
• US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
• https://www.abbvie.com/join-us/reasonable-accommodations.html

Benefits

Additional Information

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.

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