GMP Quality Investigator

As a GMP Quality Investigator at our pharmaceutical company in Malvern, PA, your main responsibilities include authoring nonconformance investigations, corrective and preventative action records, and engaging in document management. You'll be actively involved in assay trending, root cause problem-solving, and analyzing human performance factors. Another critical aspect of your role will be tracking deviations and reporting data to management, which will help in recommending corrective actions as necessary. Additionally, you'll manage change control processes and support internal and external audits.

To apply for the GMP Quality Investigator position in Malvern, PA, candidates must hold a minimum of a Bachelor’s Degree and possess 2-4 years of related GMP investigation or technical writing experience. Knowledge of current Good Manufacturing Practices (cGMP) relating to the QC laboratory is essential, along with the ability to read and interpret Standard Operating Procedures (SOPs), work instructions, and test methods.

The work schedule for the GMP Quality Investigator in Malvern, PA, begins with fully onsite training for the first two months. Once you've settled in, you can look forward to a hybrid work schedule that includes 3 days onsite and 2 days remote. This flexibility allows you to maintain a healthy work-life balance while still engaging fully with the team.

The GMP Quality Investigator role offers an attractive benefits package, including medical, dental, and vision insurance with options for Health Savings Accounts (HSA), Flexible Spending Accounts (FSA), and Dependent Care Flexible Spending Accounts (DCFSA). Other benefits include a 401(k) plan with employer matching, 10 PTO days, 6 paid sick days, and paid holidays annually. Benefits begin on the 31st day of employment, ensuring you are rewarded from the start.

Yes, the GMP Quality Investigator position in Malvern, PA is a year-long contract with a high likelihood of extension and potential for permanent hire. This pathway offers candidates the opportunity to demonstrate their skills and become an integral part of the company as they prove their capabilities within the organization.

When answering this question, provide a clear narrative that outlines the situation, your approach, and the outcome. Discuss the specific steps you took, such as identifying the nonconformance, conducting root cause analysis, and implementing corrective actions. Highlight any collaboration with cross-functional teams and use metrics or results to show your impact.

In responding to this question, mention specific techniques you've employed, such as the 5 Whys, Fishbone diagrams, or Failure Mode and Effects Analysis (FMEA). Explain how each technique contributes to understanding the underlying issues within a process, and perhaps provide a brief example of a situation where you successfully applied these methods.

To answer this question effectively, talk about the resources you utilize, such as industry publications, training courses, and webinars. Mention any organizations where you are a member, and how you participate in knowledge-sharing with colleagues to ensure compliance and stay informed about regulatory changes.

Here, describe your personal experience with Corrective and Preventive Action timelines. Include details about how you gather information, draft CAPA documents, involve stakeholders in the process, and follow up to ensure actions were implemented successfully. Highlight any positive outcomes that resulted from your actions.

In your answer, discuss your approach to prioritizing tasks based on impact and urgency. Mention any tools or systems you use to help manage workloads, such as project management software, spreadsheets, or prioritization matrices. Provide an example of a time when effective prioritization helped you meet a critical deadline.

Discuss your approach to audits and inspections by focusing on preparation, thorough documentation, and collaboration with your team. Share any specific experiences where you played a key role, underscoring your ability to respond calmly and effectively to challenging questions or situations that arose during such reviews.

Communication is pivotal in a Quality Investigator role. In your response, elaborate on how you communicate findings, engage with team members, and collaborate with other departments. Highlight your ability to tailor communication styles to different audiences, ensuring clarity and understanding across all levels of the organization.

Provide a structured response covering how you would investigate the trend, analyze its impact, and propose corrective actions. Discuss your thought process regarding data integrity, collaboration with your team for data validation, and communicating with upper management about your findings and recommended strategies.

In your answer, share a specific instance where you encountered a regulatory or standards change. Describe the steps you took to adapt, including how you educated your team, updated relevant documentation, and ensured compliance. Emphasize your ability to embrace change and maintain quality standards despite evolving requirements.

Mention specific tools or software that you've employed in your previous positions, such as LIMS (Laboratory Information Management System), QMS (Quality Management Systems), or statistical analysis software. Explain how you've utilized these tools to streamline processes, track investigations, or analyze data, showcasing your technical proficiency.