QC Quality Specialist – Investigations

NC Specialist Separations 

Location: Leiden, Netherlands

Duration: 12 months

Hours: 40 hours per week

The primary responsibility of this role is to perform, document, and manage non-conformances. It focuses on the identification of root causes, defining and implementing corrections, corrective actions, and preventive measures in accordance with Good Manufacturing Practices (GMP) and regulatory requirements. The NC specialist has a strong background in quality control, quality assurance, or a related field within the pharmaceutical industry and the ability to work collaboratively across departments to ensure product quality and compliance.

The NC specialist is situated within the Separations QC department (relevant test methods, e.g cIEF, cSDS, HPLC, particles, glidability, etc) and reports to a (Sr) Supervisor. Responsibilities are not different but focus on specific tasks may vary

roles and responsibilities

• Non-Conformance Investigation: Lead and conduct non-conformances related to testing (raw materials, in-process materials, Drug substance, Drug product) and ancillary processes.

• Non-Conformance associated records: Define, coordinate and/or implement appropriate correction/corrective & preventive actions and effectiveness checks associated with Non-Conformance records.

• Root Cause Analysis: Perform root cause analysis using appropriate tools (e.g., Operator interview, Fishbone, 5 Whys, KT analysis) and ensure comprehensive corrective and preventive actions (CAPA) are defined and implemented.

• Product impact analysis: assess non-conformances for possible impact on product quality and/or compliance status and recommend decision on product disposition

• Documentation and Reporting: Accurately document investigation findings, ensure proper and timely documentation of all related activities in non-conformance reports (NC). Maintain clear, organized records for (internal/external) audits/inspections/assessments. 

• Collaboration: Work closely with cross-functional teams, including but not limited to Quality Assurance, Manufacturing, PQM, DPDS and Regulatory Affairs, to resolve quality issues and ensure compliance with internal and external standards.

• Regulatory Compliance: Ensure all non-conformances comply with local and global procedures related to relevant pharmaceutical regulatory guidelines (e.g., FDA, EMA, ICH, cGMP) and corporate quality standards.

• Escalation: Escalate serious quality, compliance and /or GMP incidents to departmental Management and involved in Site/Global escalation meetings dependent on the scope of the issue.

• Inspections: Act as SME and participate in (the preparations of) internal audits and external Inspections, as deemed applicable.

• Continuous Improvement: Contribute to ongoing quality improvement initiatives and provide input to optimize quality systems, processes, and workflows.

• Training & Support: Contribute to developing and delivering training related to non-conformance management and investigation processes to internal staff as needed.

• Trend Analysis: Monitor and analyze trends in non-conformances to identify opportunities for improvement and help implement long-term preventive strategies. Provide input for periodic trend reports related to lab activities (e.g., OOS/OOT).

• Other: Other tasks/responsibilities related to cGMP and compliance may apply, as indicated by departmental supervisor/manager.

requirements

• Education: Bachelor's degree in a scientific field such as Chemistry, Biology, Pharmaceutical Sciences, or related discipline. Advanced degrees or certifications (e.g., Six Sigma, ISP) are a plus.

• Experience: Minimum of 3 (MSc) to 5 (BSc) years of experience in Quality Control, Quality Assurance, or a related field within the pharmaceutical industry, with preferably a focus on non-conformance management and investigation.

• Technical Knowledge: Solid understanding of relevant local and global procedures and basic understanding of GMP regulations, FDA and EMA guidelines, as well as industry best practices for quality control and compliance.

• Skills:

  • Strong analytical and problem-solving skills with experience in root cause analysis.

  • Strong communication skills (written and verbal) (English) for effective reporting and collaboration.

  • Proficiency in using the quality management systems (QMS) and investigation tools.

  • Detail-oriented with the ability to multi-task while maintaining high standards of quality.

Personal Attributes:

• Strong organizational skills with the ability to prioritize and meet deadlines.

• Proactive, self-motivated, and able to work both independently and in teams.

• A continuous improvement mindset, with a commitment to ensuring product quality and regulatory compliance.

details

This contract will run for a 12 month period. This is an onsite position. 

you are welcome here

Johnson & Johnson Innovative Medicine is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. 

questions

If you would like some additional information about the role please contact: simone.strong@randstadsourceright.co.uk

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.