Job Overview Summary The Sr Quality Analyst will play a key role in ensuring that Advarra's products and services meet the highest standards of quality, compliance and expectations of its customers and stakeholders.
This role involves conducting various assessments, reviews and audits on our products and services, identifying and resolving any issues that may affect the quality, compliance or customer satisfaction, such as errors, risks or non-conformities, and providing feedback and recommendations for improvement.
The Sr Quality Analyst collaborates with other teams and stakeholders across the company to define the implement quality standards, processes and best practices. They are expected to have a high level of expertise and experience in quality assurance methodologies, tools and best practices, as well as strong analytical, problem-solving and communication skills.
Job Duties & Responsibilities - Conduct internal audits and host audits in compliance with FDA and other applicable regulations to ensure adherence to regulatory and client requirements.
- Manage client assessments to help clients qualify Advarra for new and on-going business and do so in a timely manner while trying to convey details accurately.
- Develop and implement Corrective and Preventive Action reports (CAPAs) to address any issues identified during audits or assessments to enhance company quality performance, reduce risks, increase customer satisfaction, and comply with regulatory requirements.
- Develop and maintain Standard Operating Procedures (SOPs) to ensure that company processes are consistent and effective, help avoid errors, reduce variability, improve quality, and comply with regulations and best practices.
- Support management of suppliers to ensure that they meet Advarra's expectations; conduct audits and assessments to evaluate supplier performance and compliance with Advarra's standards and requirements.
- Maintain an appropriate level of independence; to ensure that work performed is objective, unbiased, and credible, and constructive feedback and recommendations are provided to improve the quality outcomes.
- Other duties as assigned.
Location This role is open to candidates working remotely in United States.
Basic Qualifications - Bachelor's degree or equivalent work experience.
- 5+ years' in clinical research, healthcare of GxP environment
- Ability to work independently; effectively balances team and individual responsibilities
- Ability to utilize software such as Word, Excel Access, PowerPoint, SharePoint; ability to learn new software as required and remain proficient in all programs necessary to perform duties of this position.
- Effectively and professionally communicate with all levels of staff and clients.
Preferred Qualifications - GCP experience preferred.
- Working knowledge of Federal regulations for human research and data protection (21 CFR 50, 56, 312, and 812; and 45 CFR 46, 21 CFR Part 11).
- Contributes to building a positive team environment through collaboration.
- Demonstrates accuracy and thoroughness
- Excellent organizational skills, managing conflicting demands and priorities, without compromising quality.
- Ability to exercise sound judgement and initiative.
- Ability to identify and resolve problems in a timely manner.
Physical and Mental Requirements - Sit or stand for extended periods of time at stationary workstation
- Regularly carry, raise, and lower objects of up to 10 Lbs.
- Learn and comprehend basic instructions
- Focus and attention to tasks and responsibilities
- Verbal communication; listening and understanding, responding, and speaking
The base salary range for this role is $79,000 - $137,000. Note that salary may vary based on location, skills, and experience and may vary from the amounts listed above. This position may also be eligible for a variable bonus in addition to base salary as well as health coverage, paid holidays, and other benefits.
