Red Nucleus is hiring a QA Specialist to join our Compliance team! This role can be located in any of our US offices or full-time remote.
Red Nucleus is the leading provider of strategic learning, performance, and process solutions for the life sciences industry. Our team is composed of more than 500 full-time employees whose commitment to creativity, quality, and on-time delivery is unrivaled in our space. At Red Nucleus, we work in an environment that fosters trust, self-expression, and the ability to excel in our careers. We are proud to have been recognized as one of the “Best Places to Work in PA” for all 5 years that we have been headquartered in PA.
Red Nucleus is looking for a new teammate! We are hiring a QA Compliance Specialist to join our Corporate Compliance team. This position can be based out of our Yardley, PA office. We also consider and encourage remote applicants for this role.
The Quality Assurance Compliance Specialist is responsible for ensuring compliance to internal and external controls and regulations. This role supports all aspects of SOP management, audits, vendor qualification, deviation/noncompliance investigations, CAPA implementations, and oversight of documentation for computer system validation as it pertains to Red Nucleus products and new system implementations. In addition, this role may support other quality assurance deliverables for additional Red Nucleus divisions.
How You Will Contribute
Key responsibilities include (but are not limited to):
- Interpret, build upon, and comply with company quality assurance standards.
- Contribute to the creation and maintenance of quality-related policies and procedures to ensure that they remain up to date and aligned with current best practice for the discipline and government regulations.
- Ensure appropriate training on policies and procedures is provided to company personnel.
- Maintain complaint and nonconformance processing through records and tracking systems, including root cause and corrective actions.
- Perform regular quality review and monitoring to demonstrate quality objectives are being achieved.
- Act as the lead auditor to conduct audits of vendors. The lead auditor will establish the nature of the audit (e.g., paper, physical, etc.), establish time schedules, vendor contact(s), set audit expectations, and following the audit, write the audit report to include all follow-up actions and establish a schedule for re-audit if required.
- Act as the lead auditor to host audits from clients and/or potential clients. The lead auditor will work with the client lead auditor to establish time schedules, adhere to audit expectations, and following the audit, respond to the audit report to include all follow-up actions.
- Serve as the lead for deviation and CAPA investigations resulting from SOPs, processes, or other noncompliance.
- Ensure compliance with cGxP regulations while overseeing the continual evaluation and advancement of quality standards and requirements.
- Support execution and maintenance of the Quality Management System (QMS), including change controls, document management, vendor management, risk management, and tracking/trending/resolution of noncompliance events with a focus on continuous improvement.
- Identify training needs and take action to ensure company-wide compliance.
- Develop, establish write and implement QA SOPs and supporting documentation as necessary.
A qualified candidate must be detail oriented with a high sense of self-initiative.
Ideal candidates will meet the following qualifications:
- Bachelor's degree in Life Sciences, Business or a related subject.
- At least 3 years Project Management experience.
- At least 3 years relevant audit experience.
- At least 3 years of Quality Assurance/GxP experience preferred.
- A sound working knowledge of the pharmaceutical business processes for R&D, Clinical, and/or Manufacturing.
- Understanding of software development, implementation, remediation, and planning through full System Development Lifecycle (SDLC).
- Solid understanding of computer systems compliance to FDA and other government regulations (GxP and 21 CFR Part 11) as well as processes governing data information privacy and security.
- Excellent verbal and written communication skills. This role is responsible for facilitating project reviews with executive management as well as escalating and negotiating solutions when issues arise.
- Collaborative in a team environment but also confident learning and working independently.
- Must be proficient in Microsoft Office and technology management software.
- Ability to learn new technologies, applications, and systems.
This job description has been designed to capture the essential functions of this job. It was not designed to contain or be interpreted as a comprehensive inventory of all the duties, responsibilities and qualifications required to perform this job. It is based on management’s assessment of the requirements and functions of the job as of the date this description was prepared. Management reserves the right to modify the description at any time, or to vary the duties and responsibilities of the job on a temporary or indefinite basis to meet production, scheduling or staffing needs.
Red Nucleus is an equal opportunity employer.