QC Technical Expert (Technical Team)

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Position Title: QC Technical Expert
Department Name: Quality Control
Reports To: QC Team Lead

Job Description

Position Summary:
We are seeking a highly skilled QC Technical Expert with a strong technical background in analytical techniques, particularly in Microbiology, and a solid understanding of laboratory equipment. This individual will play a vital role in ensuring the quality and compliance of our biopharmaceutical processes.

Key Responsibilities:

• Qualify analytical equipment and oversee related testing functions.
• Coordinate sampling and testing during plant and utility qualifications.
• Plan and manage the successful transfer of Analytical Methods for new market entries (NMEs).
• Oversee the analytical testing and sampling of raw materials, utilities, in-process, final bulk, and final products.
• Support and implement training programs for analysts.
• Contribute to end-to-end product launches and new product introduction (NPI) commitments to maintain high standards in operations.
• Serve as the lead for method verification related to product owner requests, ensuring on-time launches for NPIs.

Collaborate with various departments and team leaders to ensure efficient completion of QC activities.

General Scope of Responsibilities:

• Assist the team leader with daily testing operations.
• Review and approve data and QC investigations.
• Assess and approve deviations, CAPAs, and Change Control.
• Plan and oversee laboratory projects, such as method transfers and equipment qualifications.
• Identify opportunities for lab process improvements and implement them proactively.
• Train laboratory staff on specific analytical technologies.
• Provide subject matter expert support on analytical technologies.
• Participate in lean initiatives focused on lab operations, advancing documentation and qualification processes.
• Present analytical data clearly to customers, regulatory inspectors, and internal teams.
• Stay current with emerging trends in analytical technology and compliance.

Key Competencies Required:

• Strong collaboration and teamwork abilities.
• Strategic and analytical thinking.
• Exceptional problem-solving skills and attention to detail.
• Results-oriented and performance-driven mindset.
• Effective coaching and mentoring style.
• High integrity, trustworthiness, and objectivity.
• Customer-focused with excellent communication skills.
• Adaptability and flexibility in handling changing circumstances.
• Innovative and inclusive approach to work.

Individual Contributor Competencies:

• Builds and maintains productive relationships.
• Works well both in teams and independently.
• Actively seeks opportunities for professional growth.
• Implements best practices to enhance operations.
• Holds self accountable for compliant and successful outcomes.
• Takes personal responsibility for decisions that add customer value.
• Manages change effectively and adapts to new challenges.
• Shows courage in presenting independent ideas and opinions.
• Listens actively and is receptive to others' suggestions.
• Collaborates effectively with diverse styles and talents.

Qualifications and Experience:

• Bachelor’s Degree in Chemistry, Biochemistry, Microbiology, or a related field.
• 4-6 years of relevant experience in the biopharmaceutical or pharmaceutical industry, or an equivalent combination of education and experience.
• Knowledge of regulatory requirements, policies, and guidelines, with experience in QC document reviews and regulatory inspection processes.
• Familiarity with quality systems and strong technical expertise in QC analytical testing methods and equipment.
• Understanding of current Good Manufacturing Practices (cGMP) and FDA/EU guidelines is essential.

Essential Duties:

• Support cGMP routine testing related to deviations, laboratory investigations, CAPAs, and out-of-specification (OOS) results.
• Conduct data review assignments per established laboratory procedures focused on data integrity and documentation.
• Author, review, and drive laboratory documents, including protocols, reports, and standard operating procedures.
• Operate and support laboratory instruments and equipment as necessary.
• Lead and train colleagues, providing expertise as needed.
• Initiate change requests in compliance with relevant procedures and policies.
• Promptly address non-conformances and initiate Quality Issues according to established procedures, participating in investigations and providing essential information for effective CAPA implementation.
• Offer strong technical and scientific support to both internal and external customers.
• Assist with the qualification or validation of methods for the Quality Control unit.
• Participate in and lead special projects as part of the QC analytical technical team.
• Ensure effective capacity planning and manage performance of assigned tasks.