Senior Quality Assurance Associate

The primary responsibilities of a Senior Quality Assurance Associate at Repligen include ensuring compliance with ISO 9001:2015 standards, maintaining and improving the Quality Management System (QMS), conducting audits, resolving non-conformances, and providing training on quality practices. This role is essential in driving quality improvements and collaborating with cross-functional teams to elevate product and process quality.

Candidates for the Senior Quality Assurance Associate position at Repligen should have a college degree in Engineering, Quality Management, or a related field, along with a minimum of 3 years of quality assurance experience, preferably in an ISO 9001:2015-certified environment. Strong knowledge of QMS principles and proficiency in quality management software are also essential qualifications.

Repligen supports the growth of its Senior Quality Assurance Associates through opportunities for training in quality procedures, participation in continuous improvement initiatives, and access to performance evaluations. Additionally, offering a range of benefits and a competitive salary package reflects our commitment to employee welfare and development.

The expected salary range for the Senior Quality Assurance Associate role at Repligen is between $68,000 and $72,000 per year. Compensation decisions are based on qualifications, location, and internal equity, with the potential for additional cash programs and equity as part of the package.

Repligen seeks individuals for the Senior Quality Assurance Associate role who exhibit strong analytical skills, effective communication, and a collaborative spirit. Experience with root cause analysis and problem-solving techniques is also valued, ensuring candidates can effectively address and manage quality-related challenges.

In your response, demonstrate your understanding of ISO 9001:2015 standards by mentioning specific strategies like conducting internal audits, maintaining documentation control, and regularly reviewing the QMS for improvements. Illustrate with examples of previous experiences where you successfully ensured compliance.

Discuss your familiarity with both internal and external audits, including preparation, execution, and follow-up. Provide specific examples of audits you have conducted or participated in, emphasizing your ability to identify issues and implement corrective actions.

Describe problem-solving techniques you’ve utilized, such as root cause analysis or CAPA processes. Highlight a specific instance where your approach led to measurable quality improvements and discuss the impact it had on your team or organization.

Emphasize the importance of communication and teamwork. Share an example of how you worked alongside different departments to address a quality issue or enhance processes. Highlight your role in facilitating discussions and implementing changes.

Discuss your proficiency with quality management software tools, explaining how you've used them for tasks such as data analysis and reporting. If you have specific software expertise, mention this and provide examples of how it has helped you improve processes.

Share a structured process you follow for handling non-conformances and complaints, including investigation, documentation, and follow-up actions. Provide an example that illustrates your effective resolution of a customer issue.

Describe your training approach, whether it encompasses workshops, one-on-one coaching, or online resources. Provide an example of how you successfully trained a team or individual on quality procedures and the positive outcomes that resulted.

Explain how you assess, document, and mitigate risks in your quality assurance work. Describe a situation where your risk management led to a successful outcome, enhancing product quality or compliance significantly.

Mention specific resources you follow, such as industry publications, online courses, or professional organizations. Describe how you’ve applied new knowledge to your work environment to foster continuous improvement.

Convey your passion for quality assurance and the importance of contributing to high-quality products. Share personal anecdotes or experiences that illustrate your motivation and commitment to helping improve processes and outcomes.