Pharmaceutical Senior QA and QC Specialist - Group Leader

The primary responsibilities of a Pharmaceutical Senior QA and QC Specialist at Eurofins Scientific include ensuring quality assurance oversight for Quality Control processes, performing technical reviews of validation documents, approving change controls, and handling quality investigations. This role necessitates collaboration with various departments to ensure compliance with regulations and support the implementation of operational activities necessary for the start-up.

To qualify for the Pharmaceutical Senior QA and QC Specialist position at Eurofins Scientific, candidates should possess at least a Bachelor's or Master's Degree in a related field like Microbiology or Chemistry. Additionally, sufficient experience in a Quality Control environment, ideally within the pharmaceutical industry, is required. Familiarity with regulatory requirements and quality assurance processes is crucial for success in this role.

Beneficial experience for a Senior QA and QC Specialist at Eurofins Scientific includes a background in laboratory or manufacturing settings, with a strong emphasis on quality assurance and control practices in the pharmaceutical or biotech industry. Applicants with knowledge of cGMP environments, as well as experience with quality investigations, deviations, and CAPA management, will find themselves well-prepared for this role.

A Pharmaceutical Senior QA and QC Specialist at Eurofins Scientific works in a collaborative and fast-paced laboratory environment in Sanford, North Carolina. The role involves interaction with various departments and technical teams, emphasizing teamwork and effective conflict resolution. The position typically follows a Monday to Friday schedule during first shift hours, providing a great work-life balance.

Eurofins Scientific offers a comprehensive benefits package for the Pharmaceutical Senior QA and QC Specialist role. This includes medical, dental, and vision coverage, life and disability insurance, a 401(k) plan with company matching, and paid vacation and holidays, ensuring a supportive environment that values employee well-being.

In your response, highlight specific experiences where you were responsible for QA/QC processes. Detail any quality investigations you led, your familiarity with relevant regulations, and how your efforts contributed to maintaining compliance and product safety.

When answering, explain your approaches to investigating quality deviations. Discuss methods such as Root Cause Analysis and how you utilize data to identify issues, resolve them, and implement effective preventive measures.

Describe how you determine the urgency and importance of tasks within a QA/QC setting. Provide examples of past experiences where you successfully prioritized multiple conflicting tasks while maintaining quality standards.

In your answer, touch on key regulatory standards like cGMP, USP, and others relevant to pharmaceuticals. Demonstrate your knowledge of how these regulations inform your work in ensuring product quality and safety.

Focus on your negotiation and conflict resolution skills. Provide an example from your past experience where you successfully resolved a conflict within your team by facilitating communication and fostering a collaborative atmosphere.

Discuss the critical role that documentation plays in quality assurance, including compliance, data integrity, and the ability to track deviations and CAPA processes. Provide examples of documentation practices you have followed.

Share specific experiences you've had with method validation processes. Discuss any validations you conducted, protocols you followed, and how these ensured the reliability of test results.

Mention any professional organizations, publications, or seminars you participate in or follow to stay updated on industry trends. Show your commitment to continuous learning and staying informed about evolving regulatory practices.

Define what a culture of quality means to you and discuss your actions in fostering an environment that encourages quality awareness, adherence to standards, and proactive engagement in quality initiatives.

Share your admiration for Eurofins Scientific and its mission in life sciences. Highlight how your career goals align with the company's vision and how you see yourself contributing to their success in enhancing safety and quality in products.