Experienced Specialist Quality Assurance

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Learn more at are searching for the best talent for an Experienced QA Specialist to be in Sassenheim NL!

Purpose: supports the clinical and commercial manufacturing of Lentivirus an important component for Johnson and Johnsons CAR-T therapy.

The Experienced Specialist QA acts as a quality expert and ensures quality oversight of our AT products and processes. Plays a crucial role in ensuring that our manufacturing operations meet the highest standards of quality and GMP compliance by supporting various base business activities needing quality assurance expertise. You will work in close collaboration with other local or global departments (Operations Warehouse QC GET MSAT and other site Quality teams).

As an Experience QA Specialist you will:

• Assess and review the outcome of Quality Investigations provide support as part of the investigation teams and monitor the quality of the Root Cause investigations. Assesses non-conformances for possible impact on product quality or compliance status and decide on product disposition.

• Ensures that appropriate corrective and preventive actions (CAPAs) are identified and implemented in response to investigations especially those with potential impact on product quality and patient safety.

• Escalates serious quality compliance and /or GMP incidents to management and support (Global) escalation of issues which have potential impact on the delivery of products to patients.

• Participates in Hazard / Risk assessments to ensure compliance or quality is not jeopardized.

• Coordinates reviews and provides GMP training (e.g. Non-conformances Investigation techniques Qualifications etc.) for site colleagues to ensure compliance to cGMP and company training requirements.

• Provides review and approval of various document changes and change controls.

• Executes Quality Aseptic Processing Oversight activities verifying that operations are executed as supposed to and supports various Quality on the floor initiatives.

• Promotes improvement initiatives to set up standardize and lean out QA processes within the team.

• Provides Site support for local or global projects as an SME or QA core team member.

• Engages in internal audits and inspections as an SME or in support functions.

• On a rotation basis is available for beeper duty on out office hours and if quality oversight is needed during manufacturing (e.g. QAPOP)

Experience and Skills

• Degree in science related subject and /or business-related area with more 4-6 years of experience in a GMP regulated environment (manufacturing QA and/or QC) in a pharmaceutical company. Experience in a QA role for at least 2-4 years.

• Proven experience working with quality systems ensuring compliance with industry standards GMP principles and regulatory requirements.

• Knowledge of aseptic processing techniques and sterile manufacturing requirements is highly desired.

• Experience in methods such as Process Excellence Co Think or Kepner-Tregoe is recommended.

• Strong written and verbal communication skills to effectively negotiate and interact with various stakeholders.

• Problem solving analytical thinking and decision making capabilities.

• Highly organized capable of managing multiple tasks in a team environment and able to work effectively under minimal supervision while maintaining a positive attitude.

• Demonstrated proficiency in English both verbal and in writing. Dutch is a pre but not mandatory.

Salary:

The anticipated base pay range for this position is 53500.00 to 85.445.00

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

At Johnson & Johnson we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear fair and respectful of your time.

Heres what you can expect:

• Application review: Well carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If theres a good match youll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
• Final steps: For successful candidates you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Required Skills:

Preferred Skills: