QA/RA Associate
Salary undisclosed
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Fortis is a global leader in life sciences and diagnostics reagents and solutions. We partner with our customers to design, validate, and manufacture solutions to solve their complex development problems. Our teams work together across various sites, functions, & scientific disciplines to help our customers bring their innovations to market with confidence.
What You Will Do
The QA/RA Associate will be responsible for document control, training coordination, equipment support, and survey management, ensuring adherence to quality standards and regulatory requirements. The ideal candidate will thrive in a structured environment, possess strong organizational skills, and be comfortable handling multiple tasks in a fast-paced setting.
Key Responsibilities
Education / Background
We have an incredibly talented group of intelligent, down-to-earth individuals who are committed to developing and manufacturing only the highest quality products. Our mission: "Pursuing a Healthier World by Creating Tomorrow's Science Today" is complemented by our core values (EXCITE):
Excellence - We believe in solving for root cause. No shortcuts, no "band-aids"
Customer First - We prioritize the experience and outcomes of our customers above all.
Integrity - We are honest and accountable, holding ourselves to a high standard of ethical conduct.
Trust - We believe an engaged, empowered team begins with a foundation of trust. We trust our team members to make the right decisions and to be driven by and evaluated on results.
Entrepreneurship - We encourage smart risk taking. We value novel mistakes in the pursuit of innovation.
What You Will Do
The QA/RA Associate will be responsible for document control, training coordination, equipment support, and survey management, ensuring adherence to quality standards and regulatory requirements. The ideal candidate will thrive in a structured environment, possess strong organizational skills, and be comfortable handling multiple tasks in a fast-paced setting.
Key Responsibilities
- Manage the document control system, ensuring timely updates, approvals, and archiving of SOPs, work instructions, and quality records. Track document changes and ensure compliance with regulatory requirements.
- Develop, maintain, and administer training programs, including record-keeping, material creation, and scheduling sessions across departments.
- Maintain calibration and maintenance records, ensure compliance with regulatory standards, and coordinate servicing with vendors and internal teams.
- Collect, analyze, and report on customer and internal quality-related surveys to support continuous improvement initiatives.
- Assist in internal audits, non-conformance investigations, and quality improvement initiatives while collaborating with cross-functional teams to ensure compliance.
- Perform other quality-related tasks and projects as assigned.
Education / Background
- High school diploma or equivalent; associate degree or relevant certification preferred.
- 1-3 years of experience in quality assurance, document control, or a related field.
- Experience working in a regulated environment (ISO 13485, FDA, GMP, or similar).
- Experience with calibration tracking and equipment maintenance documentation.
- Strong organizational skills and attention to detail.
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).
- Ability to handle sensitive documents with discretion and accuracy.
- Strong communication and teamwork skills
- Familiarity with electronic document management systems.
- Knowledge of training coordination processes and learning management systems.
We have an incredibly talented group of intelligent, down-to-earth individuals who are committed to developing and manufacturing only the highest quality products. Our mission: "Pursuing a Healthier World by Creating Tomorrow's Science Today" is complemented by our core values (EXCITE):
Excellence - We believe in solving for root cause. No shortcuts, no "band-aids"
Customer First - We prioritize the experience and outcomes of our customers above all.
Integrity - We are honest and accountable, holding ourselves to a high standard of ethical conduct.
Trust - We believe an engaged, empowered team begins with a foundation of trust. We trust our team members to make the right decisions and to be driven by and evaluated on results.
Entrepreneurship - We encourage smart risk taking. We value novel mistakes in the pursuit of innovation.
Fortis is a global leader in life sciences and diagnostics reagents and solutions. We partner with our customers to design, validate, and manufacture solutions to solve their complex development problems. Our teams work together across various sites, functions, & scientific disciplines to help our customers bring their innovations to market with confidence.
What You Will Do
The QA/RA Associate will be responsible for document control, training coordination, equipment support, and survey management, ensuring adherence to quality standards and regulatory requirements. The ideal candidate will thrive in a structured environment, possess strong organizational skills, and be comfortable handling multiple tasks in a fast-paced setting.
Key Responsibilities
Education / Background
We have an incredibly talented group of intelligent, down-to-earth individuals who are committed to developing and manufacturing only the highest quality products. Our mission: "Pursuing a Healthier World by Creating Tomorrow's Science Today" is complemented by our core values (EXCITE):
Excellence - We believe in solving for root cause. No shortcuts, no "band-aids"
Customer First - We prioritize the experience and outcomes of our customers above all.
Integrity - We are honest and accountable, holding ourselves to a high standard of ethical conduct.
Trust - We believe an engaged, empowered team begins with a foundation of trust. We trust our team members to make the right decisions and to be driven by and evaluated on results.
Entrepreneurship - We encourage smart risk taking. We value novel mistakes in the pursuit of innovation.
What You Will Do
The QA/RA Associate will be responsible for document control, training coordination, equipment support, and survey management, ensuring adherence to quality standards and regulatory requirements. The ideal candidate will thrive in a structured environment, possess strong organizational skills, and be comfortable handling multiple tasks in a fast-paced setting.
Key Responsibilities
- Manage the document control system, ensuring timely updates, approvals, and archiving of SOPs, work instructions, and quality records. Track document changes and ensure compliance with regulatory requirements.
- Develop, maintain, and administer training programs, including record-keeping, material creation, and scheduling sessions across departments.
- Maintain calibration and maintenance records, ensure compliance with regulatory standards, and coordinate servicing with vendors and internal teams.
- Collect, analyze, and report on customer and internal quality-related surveys to support continuous improvement initiatives.
- Assist in internal audits, non-conformance investigations, and quality improvement initiatives while collaborating with cross-functional teams to ensure compliance.
- Perform other quality-related tasks and projects as assigned.
Education / Background
- High school diploma or equivalent; associate degree or relevant certification preferred.
- 1-3 years of experience in quality assurance, document control, or a related field.
- Experience working in a regulated environment (ISO 13485, FDA, GMP, or similar).
- Experience with calibration tracking and equipment maintenance documentation.
- Strong organizational skills and attention to detail.
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).
- Ability to handle sensitive documents with discretion and accuracy.
- Strong communication and teamwork skills
- Familiarity with electronic document management systems.
- Knowledge of training coordination processes and learning management systems.
We have an incredibly talented group of intelligent, down-to-earth individuals who are committed to developing and manufacturing only the highest quality products. Our mission: "Pursuing a Healthier World by Creating Tomorrow's Science Today" is complemented by our core values (EXCITE):
Excellence - We believe in solving for root cause. No shortcuts, no "band-aids"
Customer First - We prioritize the experience and outcomes of our customers above all.
Integrity - We are honest and accountable, holding ourselves to a high standard of ethical conduct.
Trust - We believe an engaged, empowered team begins with a foundation of trust. We trust our team members to make the right decisions and to be driven by and evaluated on results.
Entrepreneurship - We encourage smart risk taking. We value novel mistakes in the pursuit of innovation.