Easter Seals Jobs

Specialist Quality Control - 2406199253W

Description

Do you have a quality focussed eye and enjoy working with compliance related issue? If you know your way around medium and high-level deviations, CAPA, NPI GAP assessments and Change Controls? If the answer to these questions is yes, we are looking for you!

Johnson & Johnson is looking for a Specialist Quality Control that will actively handle the quality and compliance related issues in our Leiden location.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

What you will be doing:

You will be responsible to maintain the cGMP compliance- and LEAN status of the team and will act as Subject Matter Expert (SME) during cGMP inspections and is NPI contact person during the new product implementation process. Within the Separations team you will also take responsibility for deviation management, and lab execution related tasks.

• Acting as lead investigator for local/global Non-Conformances which encompasses conducting the investigation, providing product impact assessments, and identifying and defining appropriate corrective and preventive actions.

• Responsible for ensuring that assays can technically be executed by the departments concerned in a manner that is efficient, cGMP compliant and safe. This could be accomplished by means of the GAP analysis performed during the new product implementation.

• Act as an expert on separation technologies and will be requested to represent the team during internal/external meetings. The jobholder will act as a SME during audits and inspections and writing observation responses.

The responsibilities and the impact YOU will have:

• Supporting and advising other lead investigators from external and internal QC departments.

• You will be responsible for the proper lab investigation and CRA’s for the medium/high-level Quality issues.

• Monitor timely closure of medium/high-level investigations and associated CRA’s.

• Responsible for creating URS’s in collaboration with ELM (equipment life cycle management) team and provides lab input for the new equipment or technologies.

• Lead special projects or studies participation. Support short- and long-term projects meeting within the established timelines.

• Lead and drive continuous improvement processes.

Qualifications

We would love to hear from YOU, if you have the following essential requirements:

• Master’s degree in relevant discipline or equivalent, e.g. biosciences, pharmacy, (analytical) chemistry

• 4-6 years of relevant QC Lab experience

• Good technical writing skill in English Good knowledge of statistical data analyses Didactical skills in order to effectively transfer information in a training environment

• Strong Quality Awareness who works under supervision of management or independently with a proactive and solution driven mindset since, decisions on routine issues are taken independently. Decisions on nonroutine issues are made in consultation of management.

• Capability to manage multiple priorities and unexpected changes while having the ability to think analytical

What's in it for YOU:

• Referral Bonus

• Working Jubilee Gift

• Marriage gift

• Global Parental Leave

• Bike Plan

• Fitness allowance

• Commute allowance max 26km per day

• J&J Pension plan

• J&J Health insurance

• 36 days Holidays/Leave

• Flexible working hours

What type of mark will YOU make?

By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well and your mind. When you work at Johnson & Johnson you can touch

over a Billion lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything.

Diversity, Equity & Inclusion at Johnson & Johnson means “YOU belong”!

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

Primary Location Europe/Middle East/Africa-Netherlands-South Holland-Leiden

Organization Janssen Biologics (7266)

Job Function Quality Control

Req ID: 2406199253W