Quality Analyst Ii Jobs

Advarra provides integrated solutions that safeguard trial participants, empower clinical sites, ensure compliance, and optimize research performance. Connecting the clinical research ecosystem, Advarra delivers solutions through a site-centric approach that unifies and accelerates the drug development lifecycle, making clinical trials safer, smarter, and faster.
General Summary:
The role of the Quality Analyst will assist in the ongoing conduct of the organization’s quality program, ensuring the organization remains in compliance with Standard Operating Procedures (SOPs), Good Clinical Practices (GCP) and applicable regulatory requirements.
Principal Duties & Responsibilities (Level I):

• Assist in the use and improvement of SOPs (Standard Operating Procedures)
• Assist with problem-solving, tracking, and reporting Corrective and Preventative Actions (CAPA) investigations
• Support Supplier review processes
• Maintain a working knowledge of SOPs, Federal Regulations, Guidance Documents and accreditation standards for human research subjects’ protection
• Support Client Assessments of Advarra
• Assist with and participate in cross-functional problem-solving projects (as applicable); help establish and maintain records of quality improvement practices
• All other duties as assigned
• Assist with facilitating, hosting, and reporting of external client audits of Advarra;
• Assist with conduct of internal audits; collect, analyze, and report data and information from processes

Position Requirements (Level II):
Level II positions indicate advanced process, industry knowledge and /or sustained high performance. Prior to promotion to Analyst II, employee must demonstrate mastery of Analyst I functions in addition to sustained performance of the following areas:

• Master processes associated within the functional area
• Capably represent the team and/or functional area in intradepartmental meetings and discussions
• Assist with daily oversight of team processes
• Act as a functional area Subject Matter Expert and serve as a resource for staff training to entry level staff, and at times, managers and senior management
• Perform tasks in a consistent and superior manner in terms of volume, efficiency, and quality
• Suggest and lead process improvement initiative(s)
• Direct responsibility for or work closely with QA leadership to develop and document work instructions and procedures

Job Requirements:
Education

• Bachelor’s degree or equivalent work experience

Experience (in clinical research or GxP-regulated environment, GCP preferred):

• Excellent organizational skills, managing conflicting demands and priorities, without compromising quality
• Contribute to building a positive team environment by supporting individual efforts
• Demonstrate accuracy and thoroughness
• Effectively and professionally communicate with all levels of staff
• Level II: 3-5 years
• Level I: 1-3 years

Knowledge/Skills/Abilities

• Ability to work with complex or diverse information and data
• Able to master new systems independently from written documentation and research
• Knowledge of inspection and quality control methods, techniques, and documentation
• Excellent written and verbal communication skills
• 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
• Ability to identify and resolve problems in a timely manner
• Ability to develop and lead educational programs designed for groups and individuals
• Proficient in the Microsoft Office suite of products
• Ability to exercise sound judgment and initiative
• Working knowledge of Federal regulations for human research (21 CFR 50, 56, 312, and 812; and 45 CFR 46)
• Ability to work independently; effectively balances team and individual responsibilities

Physical and Mental Requirements:

• Learn and comprehend basic instructions
• Focus and attention to tasks and responsibilities
• Sit or stand for extended periods of time at stationary workstation
• Regularly carry, raise, and lower objects of up to 10 Lbs.
• Verbal communication; listening and understanding, responding and speaking

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EEO Statement
Advarra provides equal employment opportunity to all individuals regardless of their race, color, religion, creed, sex, sexual orientation, gender identity, national origin, age, disability, veteran, marital, or domestic partner status, citizenship, genetic information or any other status or characteristic covered by federal, state or local law. Further, the company takes affirmative action to ensure that applicants are employed and employees are treated during employment without regard to any of these characteristics. Discrimination of any type will not be tolerated.
EEO/M/F/Disabled/Vets