Quality Assurance Specialist

Science 37•Morrisville, NC

8d•Hybrid

About The Position

Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes for all. Our solutions empower life sciences companies to reach diverse populations beyond traditional means of conducting clinical research. The Quality Assurance Specialist will participate in continuous improvement of the quality system framework at Science 37 by assisting with the creation of and executing quality audit plans, supporting the identification and remediation of identified trends, overseeing the vendor management program, and executing computer system validation activities. This position provides daily, quality oversight of the conduct of clinical trials at Science 37. This position reports to the Director, Clinical Quality Assurance.

Requirements

Bachelor’s Degree in science or other related field required
2+ years of experience in clinical research or other GxP environment
Proven track record of cross functional collaboration
Knowledge of cGXP regulations, Quality Management Standards (e.g, ISO 9001). and current industry best practices
Excellent written and oral communication skills
Ability to meet deadlines in a fast-paced environment
Excellent interpersonal skills and savvy – Understands interpersonal and group dynamics and reacts in an effective and tactful manner. Has a range of interpersonal skills and approaches with ability to select a best-fit approach.
Strong organizational skills – ability to adapt to a rapidly changing work environment and remain in control of various projects and changing priorities.
Strong creative problem-solving skills and the ability to exercise sound judgment and make decisions based on accurate and timely analyses.
Ability to provide guidance and structure while encouraging innovation.
Ability to communicate in English (both verbal and written)

Nice To Haves

ISO 9001 Lead Auditor Certification a plus
Experience developing, implementing, and maintaining electronic quality management systems, direct experience with Compliance Quest desired.

Responsibilities

Leading and/or participating in client audit preparation, hosting, and follow-up.
Supporting the identification and implementation of continuous improvement opportunities and initiatives.
Assisting with the development and refinement of SOPs governing clinical and quality operations.
Assisting with the creation and execution of the internal clinical quality audit plans.
Conduct and participate in internal audits of Science 37 cGXP Departments (e.g., Clinical Operations, Nursing Solutions, Medical Affairs).
Owning and executing the Vendor Management and Quality programs.
Remain abreast of current regulations and industry best practices in clinical trials.
Participate in Quality Organization improvement projects as required.