Johnson & Johnson Careers
Senior Quality Assurance Coordinator
Requisition ID: 1805683708W
The Medical Devices segment produces a broad range of innovative products used primarily by health care professionals in the fields of orthopaedics, neurovascular, surgery, vision care, diabetes care, infection prevention, cardiovascular disease, sports medicine, and aesthetics. This segment is comprised of our Global Medical Solutions, Global Orthopaedics and Global Surgery Groups.
SENIOR QUALITY ASSURANCE CLS COORDINATOR CZ/SK/HUSE
Full-time permanent contract
The position is accountable for the coordination of execution of a Facility, Customer Service and Quality Management Systems remediation program at internal Distribution Center (DC), Customer Service and 3PL in Czech, Slovakia, Hungary, and South Est that process customer orders, receive, pick, pack, store, inspect, and deliver finished goods to Customers, Retailers, Wholesalers, and Distributors. The position serves as a supporting point of contact between Quality Assurance (QA) Customer & Logistics Services (CLS) in partner facility (internal DC Customer service and/or 3 PL) and the corresponding CLS cluster operational and Quality leads on Distribution Quality related matters (e.g. NC/CAPA, Customer Complaints).
You will have the following areas of responsibility:
Distribution and Inventory Management Processes:
- Coordination of execution of Quality Management System and Compliance elements such as documentation, record, metrics and KPIs, dashboard, training documents, document review, standard gap assessment, Consolidated supplier overview, audit schedule and audit follow-up within Hungary of the Transport & Temperature Control activities (e.g. during IBF, OBF, LTL, Parcel shipment).
- Responsible to the development / remediation controls and quality standards for providing support to QA CLS sites Senior Associates for all distribution and inventory management activities.
Special Processes (Product Testing, Repack-Relabel, Temp. Control & Monitoring):
- Assisting in the support or ensuring requirements for physical product testing (e.g. functional testing, visual inspection & verification) occurring in the Distribution Centers.
- Assisting in the support for ensuring implementation of the requirements for repackaging and relabeling operations to be conducted within the Distribution Center.
- Assisting in the support for ensuring appropriate Quality management of repacking, relabeling, over labeling, kitting, and reworking operations conducted within the Distribution Center.
- Assisting in the support for ensuring adherence to temperature control and monitoring requirements within the facilities.
- Assisting in the support for ensuring validation of temperature controlled (cold chain and controlled ambient) facilities with support and directions from the Senior Manager Temperature Control Q&C, CLS Q&C EMEA.
- Assisting in the support for ensuring appropriate investigation of temperature control excursions and subsequent remediation activities.
Quality Management Systems:
- Assisting in coordination for ensuring the appropriate handling of distribution related customer complaints including track and trend and mitigation of Quality related issues.
- Assisting in coordination the controls and quality standards for Quality systems validation, including WMS, CAPA, NC, Internal Audits, Document management software systems
- Assisting in coordination for ensuring management of Quality systems, including CAPA process and systems, document management, change control, training management, preventative maintenance systems.
- Accountable for coordination of Management Reviews of the DCs & CS.
- Accountable for the support of all Health Authority inspections conducted if required.
- Responsible for the proactive identification and mitigation of compliance risk at the DCs & CS through internal audits.
- Support the department appropriate goals and objectives, and business measurements.
Qualifications and experience of the successful candidate:
- 5+ years in Quality Assurance within Pharmaceutical, Medical Devices or FMCG business
- University level education Chemistry/Pharmacy/Microbiology/Medicine
- Knowledge of GMP and GDP preferred
- It is preferred that the job holder is an experienced internal auditor or certifies lead auditor
- Change management and project management experience
- DC Q&C management
- Understanding the linkages in quality and regulatory compliance in delivery to customer and health authority
- Compliance experience, QMS experience
- Strong presentation skills, collaborative approach, organized, “hands-on” operational orientation
- Native in Polish & fluent level of English
What do we offer:
- Interesting job in a prestigious international healthcare company
- Highly professional environment and highly competitive innovative product portfolio
- Friendly and supportive team members and management
- Opportunities for professional growth and career development
- Possibilities to take part in different projects
- Motivating financial remuneration and non-financial benefits
If you are interested in this role and you fulfill the requirements set above, do not hesitate to send us your CV and brief cover letter in English via MyNextStep.jnj.com, EmployeeReferrals.jnj.com or via Careers.jnj.com
Johnson & Johnson (Poland) Sp. z.o.o. (7815)