Quality and Compliance Staff Analyst (CLS) – J & J Consumer Inc. – Tobyhanna, PA, USA
Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.
Johnson & Johnson Customer & Logistics Services (CLS) is a global Supply Chain organization that supports operating units across all of the Johnson & Johnson Family of Companies.
CLS strives to deliver an exceptional customer experience through leading critical customer facing-functions such as distribution and transportation. In addition, CLS oversees critical business enablers, including how we gather and manage supply chain master data, safe and secure supply chain practices, product identification standards, and market/channel access capabilities. CLS supports all three sectors of Johnson & Johnson: Medical Device & Diagnostics, Pharmaceutical, and Consumer Products. This team is represented in multiple countries, and continues to grow globally in both visibility and responsibility. The CLS team reports to Johnson & Johnson Supply Chain and partners closely with groups throughout the supply chain organization.
Johnson & Johnson Customer & Logistics Services is recruiting for a Quality and Compliance Staff Analyst (CLS), located in Tobyhanna, PA.
The CLS Q&C Staff Analyst is responsible to support and execute Quality Management Systems and compliance with applicable laws and regulations at the Distribution Center that receive, pick, pack, store, inspect, and deliver finished goods to Customers, Retailers, Wholesalers, and Distributors. Lead distribution and inventory management across 3 Consumer DCs.
Support implementation of departmental strategies and services as the commercial business expert on quality systems, distribution, and quality management. In collaboration with Enterprise CLS Quality and other sectors, execute and support common distribution standards and Quality Management Systems (where appropriate) and implements accordingly. Responsibilities include:
Distribution and Inventory Management Processes
• Accountable to support and execution for all distribution and inventory management activities (e.g. receiving, pick, pack, lot reconciliation, reverse distribution, destruction process, quarantine, hold, stop-ship, recall, refusals, donations, destructs authorization, discontinuation, returns, disposal, and McNeil Monthly Inventory assessment, etc.)
• Responsible for ensuring returned product is disposition according to procedures or predefined agreements with Source co., Franchise, or Marketing Co.; responsible for resolving discrepancies in a timely fashion with appropriate partner.
• Accountable for execution of robust product disposition procedures and the quality oversight of all product quality holds, stock removal, stop ship extension and field actions impacting the Distribution Centers.
• Perform required second person review of Shipping Summary Reports (SSRs) and Perform review of inventory assessment gains
• Responsible to support the company’s quality and distribution process capabilities against company and industry standards and regulatory expectations.
• Responsible to support for monitoring of calibration and preventive maintenance systems.
Special Processes (Product verification/assessment for Loaner Kit, Repack-Re el, Temp. Control & Monitoring)
• Performing physical product verification in DC (incoming) (e.g. temperature, visual inspection & verify.) as well as Quality oversight in disposition of damaged packages (incoming) according to procedures or predefined agreements with Source co., Franchise, or Marketing Co.
• Performing physical product assessment external as well as evaluating McNeil in-transit temperature excursion and handling events (incoming) (e.g., temperature monitors, visual inspection & verify.)
• Supporting QA release of product repackaged, relable, kitted, and reprocessing within the DC
• Supporting and executing requirements for repackaging and relabeling operations to be conducted within the Distribution Center and support assessement of repackaging and re relabeling requests and partners with business partners to meet requirements.
• Supporting Quality management of repacking, relable, kitting, and reprocessing operations conducted within the DC
• Supporting adherence to temperature control and monitoring requirements within facility and during transportation.
• Supporting validation of cold chain facilities, and validation of cold chain and controlled ambient pack out.
• Executing product disposition execution and rejection notifications as per Business Quality decision.
• Accountable for accurate and timely communication of temperature control excursions occurring within the DC to appropriate partner
• Executing Quality investigation of temperature control excursions and subsequent remediation activities
• Support projects related to storage, handling and distribution activities
Quality Management Systems
• Responsible to support the appropriate handling of distribution related customer complaints
• Responsible for escalation management to Make QA/BQ and Franchise QA as well as commercial business organizations and CLS operations partners.
• Create, review and approve assessment plans, risk assessment reports, non-conformance reports, corrective and preventative actions, audits, and other documentation. Support leadership and compliance activities including, but not limited to the creation and revisions of global and local procedures.
• Support the evaluation of overall compliance risk, Recommend corrective actions and track progress.
• Provide metrics as required
• Perform required second person review of shipping, summary reports (SSRs)
• Support all Health Authority inspections (e.g., FDA) as well as other logistics and transportation related inspections (e.g., TSA, ISO, DEA, DOT and JJRC) conducted.
• Understands current and emerging regulations and the impact to quality and distribution practices.
• Review and provide guidance to 3PLs on creation and revisions for their procedures, to ensure alignment with J&J quality agreements, service contracts, and JJSLC procedures and policies.
• Provides interpretation support of policies and regulations to unique site requirements and problems and acts as quality representative for management initiatives.
• Support innovation within functional area while ensuring functional initiatives are delivered in a compliant, cost efficient manner.
• Pull duplicate product samples in the event product samples are taken by a Regulatory Authority either at the DC or in-transit to the DC. Pull stability samples as required to adhere to McNeil Annual Stability Plan
Distribution Supplier Quality Management
• Support execution of Quality Agreements with distribution, logistics, transportation, and material suppliers
• Support qualification of distribution, logistics, transportation, and material suppliers
• Bachelor’s degree required.
• Engineering, Life Science, and Technical scientific or related discipline is preferred.
• A minimum of 6 years of experience in a highly regulated industry is required.
• QA/QC experience in the Medical Device, Pharmaceutical or consumer products industry and experience with regulatory inspections is required.
• Strong knowledge of FDA 21 CFR Part 11, 210, 211, 820 and/or ISO 13485 are required.
• Six Sigma, Lean, 5S or ASQ Certification and trainings are preferred.
• This position will require up to 30% travel.