• Responsible for E2E operations conducted in PQC Sample Room
• On site support 5 days/week, ability to work wearing PPE
• Responsible for handling used complaint samples
• Process returned complaint samples as per PQC Sample Room Manual
• Identifies and handles lot discrepancies correctly with returned complaint samples.
• Updates the complaint records in the systems.
• Prepares products for shipments to the manufacturing sites
• Prepare shipping labels using FedEx equipment.
• Assemble shipping containers to the sites
• Responsible for resolving all discrepancies directly with the reporters
• Create new complaints in both Meteor and Qualipso
• Identify complaints for FAR/BPDR (Field Alert and Biological Product Deviation Report) reporting as necessary
• Use various Excel reports for daily operations.
• Act as a SME on PQC Sample Room operations and provide support during audits and inspections
• Act as a trainer for new associates
• Manage PQC Sample Room Manual
• Complete all required trainings (i.e. DOT, IATA, blood borne pathogens)
• Manage all supplies and maintain inventory required for daily operation of a PQC Sample Room
• Order supplies and work directly with the vendors for customized PO
• Responsible for maintaining all equipment and tools in PQC Sample Room
• Proficient with use of all databases within the department (ie. Meteor, Qualipso, Microsoft Office).
• Understands the importance of processing GxP data according to GDP foundations
• Understands PQC process flow
• Understands the FDA complaints regulations for the drug, combinations products and medical devices.
• Maintains PQC reports as needed
• Understands export shipping requirements for shipment of waste pharmaceuticals to overseas manufacturing sites.
• Prepare international shipping manifests, commercial invoices and customs forms
• Provides complaint support to other company departments including Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial, Operations, Legal, and Risk Management.
• Performs other duties as assigned.
• Ability to lift/move 20lb and work standing 50%
• Maintains use of Universal Precautions while working
...About DiBona Dental Group: At DiBona Dental Group, we pride ourselves on providing high-quality dental care and fostering a welcoming... ..., and we are looking for a skilled and passionate Dental Hygienist to join our dynamic practice. If you're committed to preventive...
...Job Title: Executive Assistant Location: Phoenix, AZ Employment Type: Full-Time, On-Site Schedule: Monday - Friday Job Description: We are seeking a highly organized and proactive Executive Assistant to provide comprehensive administrative support to 5-8...
...DEPENDENT ON YOUR AVAILABILITY) JOB TYPE: Full-Time, Part-Time LOCATION: Gilbert, AZ Description: NControl Driving School is seeking Driving Instructors to join our team in Gilbert, AZ! You will be responsible for training new drivers in an in-car setting. The role...
...health assessments and performance optimization. Trusted by leading medical centers, military, and sports organizations, our mission is to... ...skills. Proficiency in CRM software and Microsoft Office. Must live in Northern California. Bachelors or Associate...
...WFH Data Entry Specialist Mamaroneck Union Free School District is seeking a highly organized and detail-oriented WFH Data Entry Specialist... ...of our records. This is an excellent opportunity for an entry-level candidate to gain experience in data entry and contribute to...