Quality Assurance Packaging Line Inspector

Essential Duties and Responsibilities

Responsible for the overall product quality on the packaging line, approval of line clearance and documenting all activities on the packaging line in accordance with proceduresIssuance of Master batch records, generation of Bill of Materials (BOMs) for packaging and assurance that all material/components used in the packaging run are in accordance with the appropriate BOMMaintain, complete, review and control packaging batch records to assure appropriate completion and handling of recordsPerformance and accurate documentation of in process inspections and retain/ customer samplesMaintains appropriate control and labeling of finished goods materials leaving the packaging area (status of Finished Goods as Released, quarantined, etc.)Assures appropriate usage, disposition and destruction of unused Packaging components, including cartons, labels and insertsPerforms special projects and assignments as indicated by Quality ManagementAssist in maintenance and revision of procedures related to Quality Assurance activities on the packaging lineTo communicate any issues affecting the packaging line during line clearance, line setup and during inspectionsTo provide oversight and assistance to the packaging team with any quality issuesTo communicate any issues affecting manufacturing and packaging, safety concerns, personnel concerns to the appropriate managers and work with them to resolve any issuesTo be an active Quality Assurance team member and work with the department on resolving all issues related to product quality support overtime as needed

Key Competencies (knowledge, skills, and abilities every person must possess to be

successful)

Critical Thinking — using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problemsExcellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customersExcellent verbal and written communication skillsCreative and able to present various solutionsEnergetic, enthusiastic and motivational dispositionMaintain confidentialityCoaching skills

Education/Experience

Minimum of 2 years degree in science or technical field3+ years of experienceStrong understanding of pharmaceutical cGMP, industry standards, and regulationsStrong verbal and written communication skills with the ability to interact across functions, departments, and seniority levelsKnowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems including SAP and TrackWiseAbility to explain problems, solutions and make recommendationsAbility to handle various urgent requests in a professional mannerAttention to details and organizational skills when handling all activities related to batch records