QC Analyst - Pharma (Assays, CAPA, Stability Max $39/hr W2)

As a QC Analyst at Pharma, your primary responsibilities include conducting thorough quality testing for in-process, final products, and stability studies. You'll also run test samples for various investigations and validations, review assays, and document quality records such as deviations, CAPA, and change control. This role demands a collaborative approach as you will be involved in training colleagues and participating in method transfers and qualifications.

To be successful as a QC Analyst at Pharma, candidates should possess a strong foundation in analytical techniques such as A280, CE-SDS, icIEF, ELISA, SoloVPE, and qPCR. Familiarity with GMP quality systems like TrackWise and LIMS is highly beneficial. Additionally, proficiency in Microsoft Office Suite and the ability to apply data integrity principles in compliance with company policies are essential qualifications.

The QC Analyst at Pharma significantly contributes to production by ensuring all products meet stringent quality standards through detailed testing and assessment. By engaging in technical transfers and method qualifications, you help ensure that production operations run smoothly and efficiently, ultimately supporting our commitment to deliver high-quality pharmaceuticals.

In the role of QC Analyst at Pharma, you will utilize several testing methods, including A280, CE-SDS, icIEF, ELISA, SoloVPE, and qPCR. These methods are critical for quality evaluation during in-process control, lot release, and stability studies, allowing us to maintain our high standards in product safety and effectiveness.

The work environment for a QC Analyst at Pharma is collaborative and supportive, focusing on teamwork and compliance with quality standards. The team values open communication and continuous improvement, ensuring that all employees are equipped with the necessary tools and training to excel in their roles.

In an interview, you can explain your familiarity with quality control testing methods such as A280, ELISA, or qPCR. Discuss specific projects where you applied these techniques and the outcomes you achieved, showcasing your ability to adhere to stringent quality guidelines.

Be prepared to mention any experience with GMP, TrackWise, or LIMS. Highlight how you have used these systems in past roles to ensure compliance and maintain high quality standards, illustrating your familiarity with the regulatory requirements in the pharmaceutical industry.

Discuss specific strategies you employ for task prioritization, such as assessing deadlines, the significance of each task, and the impact on overall production and quality. Use examples from previous experiences where your organizational skills led to successful outcomes.

Explain your understanding of data integrity principles and the importance of maintaining accurate records. Discuss practices you follow, such as regular audits, compliance checks, and thorough documentation, showing how you contribute to a culture of quality.

Share a specific example where you noticed a deviation from standard procedures. Outline the steps you took to investigate and rectify the situation, including communicating with team members and creating necessary documentation like CAPA or deviations.

Highlight your approach to training, emphasizing your ability to create a supportive learning environment. Share examples of training materials or sessions you've developed, and how you ensure that new hires understand quality control processes effectively.

Discuss your experience with writing quality records such as deviations, CAPA, and change controls. Provide examples of how these records were crucial for ensuring product quality and compliance, and your process for maintaining accuracy and clarity in these documents.

You could mention specific resources, such as industry journals, webinars, or training sessions you regularly engage with. This demonstrates your commitment to continuous learning and ensuring compliance with the latest regulations in the pharmaceutical industry.

Share a relatable challenge you encountered in a QC position, focusing on your problem-solving skills. Discuss how you approached the situation, the resources you utilized, and the lessons learned, showcasing your resilience and adaptability.

This is your chance to express genuine enthusiasm for the role and the company. Discuss your passion for quality assurance in pharmaceuticals, your alignment with Pharma's mission, and how your skills and experiences make you a perfect fit for the QC Analyst position.