Quality Specialist, Quality and Compliance Consulting

Overview

You’re driven, resourceful, and above all else – remarkably smart.

You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn’t cut it – you’ve got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you’re known for your good nature. You’ll fit right in at Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.

Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 21,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.

Here, there’s no shortage of challenging work, learning and opportunities. Because we offer many services to varied clients, our knowledgeable professionals gain experience across a large section of the industry. Our client roster consists of more than 550 organizations including all 20 of the largest global biopharmaceutical companies.

Responsibilities

• End-to-End Corrective and Preventive Action (CAPA) management systems implementation and support
• Work with business stakeholders on development of CAPA and effectiveness checks and follow-up with CAPA owners and Subject Matter Experts (SMEs)
• Liaise with business stakeholders through CAPA Lifecycle Management
• Track CAPAs through to completion, including updates to senior management and escalations as required
• Assist in follow-up of open and overdue CAPAs with key business stakeholders to ensure accuracy and quality of data
• Perform gap analysis of Quality systems and procedures and provide insights and feedback on continuous improvement areas
• Develop and implement streamlined Standard Operating Procedures (SOPs)
• Support client projects to establish or transform SOPs and associated controlled documents across the GxP spectrum, comprising text SOPs /policies /associated documents, smart forms and templates
• Develop processes and flow charts in Business Process Mapping cloud environment.
• Conduct quantitative and qualitative benchmarking and primary and secondary analyses of large and complex data
• Research the GxP standards, regulatory authority websites

Job Requirements

Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:

• BA/BS degree in the science/health care field or equivalent combined education and experience.
• One (1) to Three (3) years’ Pharmaceutical or Healthcare related industry experience. 
• Prior experience of working on clinical studies/trials.
• Prior experience in authoring SOPs (within the GCP/GMP and any other GxP space).
• Strong knowledge of all applicable Good Clinical Practice /other GXP regulations (as applicable) and guidelines. Knowledge of medical terminology preferred.
• Well-developed communication skills and the ability to write and present concise, accurate documentation.
• Ability to handle multiple tasks to meet deadlines in a dynamic environment and to adapt to work at different time zones.
• Strong organizational, presentation, documentation and interpersonal skills with diverse cultures.
• Ability to negotiate and provide constructive feedback.
• Must be able to work as part of a team as well as independently.
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail.

Make your work matter everywhere. Be a driving force in a rapidly evolving healthcare industry.

 
#LI-MD1
#LI-Remote