What are the responsibilities and job description for the Senior Analyst QRC Operations position at CREO?
The Senior Analyst, Quality & Regulatory Compliance, will be responsible for providing support on producing client deliverables, facilitate discussions with clients to gather technical requirements and supporting Computer System Validation (CSV) design, development, and/or testing based on areas of proposed improvements.
This individual will have effective communication and customer service skills; a business mindset; and strong quality & regulatory compliance experience. The Senior Analyst will have a strong understanding of Computer System Validation and Data Integrity principles ensuring compliance with regulatory requirements and will support quality, privacy, security and 21 CFR Part 11 assessments. The Senior Analyst will have the ability to proactively author and review numerous technical and process-related documents and contribute to the preparation of weekly reports, final reports, and project metrics.
Position Responsibilities: vary based on project and technology, but may include:
Experience
The following are critical experience elements for the Senior Analyst:
CREO, Inc. is the preferred consultancy to the world’s most promising companies that seek to improve human health. We serve growing life sciences, healthcare, and private equity portfolio companies. Our expertise and knowledge in Strategy, M&A, Digital Transformation, Cybersecurity, and IT Quality & Regulatory Compliance help organizations improve today’s business performance and develop tomorrow’s clinical innovations. Founded in 2015, CREO is headquartered in North Carolina’s Research Triangle Park. Join us and together let’s make a meaningful difference. Visit CREO at www.creoinc.net.
This individual will have effective communication and customer service skills; a business mindset; and strong quality & regulatory compliance experience. The Senior Analyst will have a strong understanding of Computer System Validation and Data Integrity principles ensuring compliance with regulatory requirements and will support quality, privacy, security and 21 CFR Part 11 assessments. The Senior Analyst will have the ability to proactively author and review numerous technical and process-related documents and contribute to the preparation of weekly reports, final reports, and project metrics.
Position Responsibilities: vary based on project and technology, but may include:
- Working in a team-based environment to support one or more workstreams, confidently assist senior staff, and work directly with clients across multiple projects and engagements.
- Collect data for analysis of business problems and issues; perform quantitative and qualitative analysis to drive the proposed solution.
- Interview client key stakeholders, research, gather, and organize information, analyze data, and prepare reports that summarize findings.
- Providing support on producing client deliverables, facilitate discussions with clients to elaborate on the areas of proposed improvements.
- Gathering technical requirements and supporting Computer System Validation (CSV) design, development, and/or testing based on requirements.
- Author, review and implement CSV deliverables in a GMP environment.
- Follow up with clients to ensure the provided solution is working and support communication and project updates with stakeholders and various levels of management.
- Participate in Business Process Improvement initiatives aimed at streamlining operations, optimizing processes, and enhancing overall efficiency.
- Look for new opportunities to market the firm’s services to new and existing clients.
Experience
The following are critical experience elements for the Senior Analyst:
- BS/BA degree or equivalent combination of education and work experience in healthcare and life sciences industry.
- 7-12 years overall Quality and/or system implementation experience.
- Exposure to quality compliance assessments (QCA), change controls and investigations and core QMS technology
- Bachelor’s degree in business, engineering, or scientific field
- Exceptional verbal and writing skills
- Expertise in Excel, PowerPoint, Word, and Outlook
- Ability to work on tight deadlines, multi-task, and manage multiple shifting priorities
- Experience in change management and support of technology transformations.
CREO, Inc. is the preferred consultancy to the world’s most promising companies that seek to improve human health. We serve growing life sciences, healthcare, and private equity portfolio companies. Our expertise and knowledge in Strategy, M&A, Digital Transformation, Cybersecurity, and IT Quality & Regulatory Compliance help organizations improve today’s business performance and develop tomorrow’s clinical innovations. Founded in 2015, CREO is headquartered in North Carolina’s Research Triangle Park. Join us and together let’s make a meaningful difference. Visit CREO at www.creoinc.net.
Senior Sales Operations Analyst # 4017
BioSpace -
Raleigh, NC
Senior IT Business Operations and Communications Analyst
US51 Clorox Services Company -
Durham, NC
Automotive Senior Technician
TX06 Bridgestone Retail Operations, LLC. -
Pendleton, NC