Quality & Compliance Analyst Job – Johnson & Johnson – Shepherdsville, KY, USA
Janssen Pharmaceutical, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Quality & Compliance Analyst. The position will be based in Shepherdsville, KY.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Q&C Analyst is responsible for the execution of Quality Management Systems and compliance at JOM distribution centers (DC). The Q&C Analyst serves a single point of contact to the local site quality head on distribution quality related matters and liaises with multiple quality organizations to drive timely resolution of quality related issues. The Q&C Analyst identifies opportunities to continuously improve quality, cost and time factors, consistent with both Sector and CLS business objectives. Identifies significant business issues, prioritize for action, and lead improvement opportunities and problem solutions. The Q&C Analyst implements and executes quality assurance programs designed to ensure effective and consistent processes with established standards by performing the following duties.
Responsible for quality in product receiving process (including receiving inspection) within the DC. Responsible for quality oversight of quarantine/hold/stop-ship and recall processes within the DC. Responsible for quality oversight of pick/pack/and ship operations, including trending of pick/pack/ and ship errors.
Responsible for physical product testing in DC (incoming) (e.g. functional testing, visual inspection & verification). Responsible for the quality release of product repackaged, relabeled, over labeled, kitted, and reworked within the DC. Responsible for validation/monitoring of cold chain facilities/areas and ambient pack out & transportation lanes. Responsible for validation/monitoring of ambient environment (temperature and humidity as required), and temperature control shipments (outgoing). Responsible for the identification and communication of temperature control excursions occurring within the DC to appropriate partner. Responsible for the quality investigation of temperature control excursions and subsequent remediation activities.
Responsible for departmental representation for validation of Warehouse Management Systems. Responsible for management of nonconformance and CAPA processes and systems. Responsible for quality records and document management. Responsible for departmental representation for validation, implementation, and changes of calibration/preventive maintenance, CAPA, nonconformance, and document /training management software systems (e.g., DocSpace, ComplianceWire) and document management oversight. Responsible for quality oversight of current standard operating procedures (SOP) and work instructions (WI) in the DC, including SOP/WI development, review and approval. Responsible for departmental representation for change control process. Responsible for departmental representation for training management, including operator certification. Responsible for monitoring of calibration and preventive maintenance systems. Responsible for the capture and processing of DC quality complaints reported to DC (product and service related complaints). Responsible for internal Quality Agreements between CLS and local operating company / Franchise.
Responsible for conducting internal/external quality audits of DCs (schedule, plan, conduct, follow up). Responsible for partnering with RTO, ESQI and Enterprise Supplier quality groups in the establishment of Quality Agreements with distribution, logistics, transportation, and material suppliers, as appropriate. Responsible for ensuring compliance to CFR 210, 211, 820, DEA, TSA and ISO9001 certification requirements, including requirements for obtaining and maintaining certification.
A Bachelor’s Degree with a minimum of 4 years Quality Assurance experience OR a high school diploma with a minimum of 8 years Quality Assurance experience is required. Experience in the Pharmaceutical, Medical Device, and/or Consumer industry is required. Demonstrated experience in investigative and/or technical writing in GMP/MD environments is preferred. Demonstrated proficiency in organizational and project management skills is preferred. Working knowledge of SAP, quality investigation management systems (e.g., EtQ,Trackwise), document management (e.g., DocSpace), training systems (e.g., ComplianceWire), and warehouse management systems is preferred. Knowledge of and demonstrated skills in sampling methodologies (e.g. ANSI/ASQ standards) is preferred. Ability to document work clearly and accurately, and to communicate and present effectively to peers and/or management representatives within a group and/or individual setting is required. Ability to work in a team environment and/or independently as the situation requires is required.
This position will be located in Shepherdsville, KY and will require 10% of travel.
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J2W: LI NA
Primary Location: North America-United States-Kentucky-Shepherdsville
Organization: JOM Pharmaceutical Services, Inc. (6162)
Job Function: Quality Assurance
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