Sr Associate, QA

Description

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life.

Discover what our 29,000 employees, across 110 countries already know.

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program.
• We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job Responsibilities

JOB SUMMARY

Supports the auditing team in gathering documentation for audits and inspections and tracking schedule of

audits and inspections in the enterprise quality management system.

JOB RESPONSIBILITIES

General Profile

. Assists in the tracking of planned and scheduled audits and inspections in the enterprise quality management system.

. Updates audit schedules and calendars as requested by management.

. Assists in gathering documentation required by auditors for audits and inspections (e.g. training records, organization charts).

. Assists auditors in obtaining follow-up information during customer audits and regulatory inspections.

. Maintains, files, and archives relevant Quality Assurance (QA) documentation.

. Enters audit-related data into the enterprise quality management system.

. Develops appropriate tools, templates, and guidance documents for managing audits and inspections.

Supervision

. Requires some instructions on day-to-day work and new assignments.

Other tasks

. Performs other work-related duties as assigned.

. Minimal travel may be required (up to 25%).

QUALIFICATION REQUIREMENTS (please indicate if preferred)

. Requires a Bachelor's degree or equivalent with minimal experience in a health care or clinical research environment.

. Computer literacy commensurate with job requirements (Microsoft Office suite basic Sharepoint proficiency).

. Able to handle multiple tasks to meet timelines in a dynamic environment.

. Strong organizational, presentation and interpersonal skills.

. Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds.

. Well-developed communication skills and the ability to write necessary documentation (e.g . tools).

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.