Senior Quality Assurance Associate – CLS Q&C
Tingley, Leeds, United Kingdom
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Quality team of DePuy Synthes offers exciting career opportunities for high calibre professionals. We provide value by delivering superior supplier quality performance, supporting our internal and external customers and by developing outstanding talent. At DePuy Synthes, a continuing focus on being agile, efficient and effective for the future is at the heart of what we do.
We have a fantastic opportunity for a Senior QA Associate to work in the CLS (Customer & Logistics Services) section of the business based at the Tingley Distribution Centre which supports the handling, storage and distribution of all products cross sector within the UK. This role is ideal for someone who wants to progress their career within a technical field of experts and suppliers. You will be accountable for the oversight of the Quality Management Systems and compliance within the 3PL (third party logistics) sites within the UK that receive, pick, pack, store, inspect, repack/relabel and deliver finished goods to Customers, Retailers, Wholesalers, and Distributors reporting to the UK CLS Quality manager.
You will plan, coordinate, and direct quality assurance programs designed to ensure effective and consistent processes with established standards by performing the following duties personally or through the team.
What you’re great at:
You will have a quality management focus and be able to work effectively across many different functions, Sectors and suppliers which will ensure that we meet both the customer and the business needs. You will have a strong sense of personal responsibility and be able to work both as an individual leader and be a strong team player.
It goes without saying that you will always operate with a continuous improvement mindset, looking for areas in which we can create efficiencies and better working practices. You'll be great at establishing clear expectations and collaborating with internal and external partners that lead to consistent, reliable, quality products and services rather than operating in a policing fashion.
As a Senior QA Associate, your typical day may include:
- Responsible for execution and overseeing the controls and quality standards for all distribution and inventory management activities (e.g. receiving, pick, pack, lot reconciliation)
- Responsible for evaluating the company’s quality and distribution process capabilities against company and industry standards and regulatory expectations.
- Accountable for defining and implementing requirements for physical product testing (e.g. functional testing, visual inspection & verification) occurring in the DCs or outsourced by the DCs.
- Responsible for defining, designing and implementing requirements for repackaging and relabeling operations to be conducted within the Distribution Center to assess repackaging and relabeling requests and collaborate with business partners to meet pre-defined requirements.
- Accountable for validation of temperature controlled (cold chain and controlled ambient) facilities with support and directions from the Sr. Manager Transportation and Temperature Control Q&C, CLS Q&C EMEA.
- Responsible for overseeing the controls and quality standards for Quality Systems validation, including WMS, CAPA, NC, Internal Audits, Document Management software systems.
- Responsible for attending the 3PL Management Reviews
- Responsible for the successful management of all Health Authority inspections (e.g., FDA, MHRA, etc.) as well as other logistics and transportation related inspections (e.g., TSA, DEA, etc.) conducted.
- Responsible for the proactive identification and mitigation of compliance risk at the DCs through QScan, internal audits, and other compliance programs.
- Supports for establishing Quality Agreements with, qualifying of, and Q&C management of distribution, logistics, and material suppliers (excluding Distributors).
Ideally you will be degree qualified with demonstrated experience of working in a regulated environment within Pharma or Consumer. You will manage complexity successfully whilst offering a collaborative approach to all issues.
You will also have proven success in:
• DC Q&C management
• Understanding the linkages in quality and regulatory compliance in delivery to customer and health authority
• Compliance experience, QMS experience
• Change management and project management experience
• Strong presentation skills
• Issue remediation experience
• Analytical skills with a Bifocal approach - ability to zoom-in/zoom-out for tactical, high-level and detailed, etc.
To be a success in this role you will be proactive, independent and committed, with a can do attitude which will enable you to build effective relationships and networks locally/globally. You will be able to make complex issues clear and transparent and be a strong problem solver.
In return for all this great work, you’ll own and you’ll grow by:
This position will give you great visibility to showcase your talents and develop your career. This role will give you the opportunity to work with market leaders in this field, you will visit their facilities and gain great exposure to our partners.
This role is a very broad and will keep you motivated by offering you a varied experience that you can build on every day.
If you are ready for your career to excel to the next level then this is one in a life time chance to join the world’s leading health care provider.
What we’re about:
We are passionate about our work, and play vital roles across a range of professional disciplines caring deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and influential careers. We are
• Committed to caring
• Responsible to our communities
• Ready to apply our knowledge and know-how
• Unique in our background and experiences
• The drivers of our own success
• Passionate about doing what’s right
Make a unique mark in your career
CLOSING DATE: 29th May 2018
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Depuy Int'l Ltd. (8722)Job Function