Commercial Quality Assurance Specialist

Updated: November 23, 2021
Location: Nationwide
Job ID: 138130


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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.

 

Responsibilities

The Commercial Quality Assurance Specialist (CQAS) is an essential member of the Commercial PMO, engaged in supporting internal process definition and controlled documentation, supporting internal and external audit preparation and follow-up, and as a liaison to the Corporate Quality team.

Job Responsibilities

The Commercial Quality Assurance Specialist (CQAS) is an experienced healthcare or pharmaceutical professional who is responsible to review the internal processes to verify they meet Syneos and client-specific requirements.

The CQAS works closely with the Syneos Corporate Quality team who are responsible for performing scheduled internal audits. The CQAS will manage the follow-up projects that are developed following the internal audit, e.g., internal process improvement. 

The CQAS will serve as an SOP Liaison and will manage the final/finished product and project quality document control to verify these identified improvement items have been completed in compliance with all applicable policies, standards, plans and specifications, and/or client requirements and expectations – including appropriate training/internal communication.

The CQAS will uphold quality standards with attention to details.

The CQAS will be responsible for conducting independent research of Commercial project documents, codes, standards and other research to ensure the applicable requirements are instituted.

The CQAS will be responsible for Commercial process improvement initiatives.

The CQAS will be a self-starter and will work independently.

The primary goal of the CQAS is to verify the processes that we follow meet the highest standards and contractual requirements.

Essential Duties and Responsibilities: 

  • Review and be knowledgeable in the specifications for products or processes. 
  • Promote adherence to internal process and contractual obligations, and appropriately escalate issues or concerns. 
  • Perform project audits (in collaboration with Corporate Quality) to verify processes and procedures, quality standards, and quality documentation is being met and properly completed. 
  • Work with Commerical organization team to find practical solutions, and verify remedies are completed in a timely manner and to the project specifications. 
  • Keep accurate documentation and perform statistical analysis. 
  • Submit detailed reports to Commerical Leadership
  • Be on the lookout for opportunities for improvement and develop new, efficient procedures. 
  • Reliable, responsible and works well independently 
  • A keen eye for detail and a quality product 
  • Excellent verbal and written communication skills 
  • Excellent organizational skills 
  • Ability to conduct and effectively facilitate audits and meetings 
  • Ability to create, complete and provide feedback on audit forms and processes 
  • Willingness to travel (~10%)
  • Strong ability to learn and adapter to new processes and procedures 
  • Proficient in MS Office (TEAMS, EXCEL, PowerPoint)
  • Strong presentation skills
  • Ability to simplify dry/complex concepts
  • Must bring practical real-world approach must have business savvy
  • Performs other work-related duties as assigned

Job Requirements

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

Qualifications

  • Bachelor’s degree, or equivalent combination of education, training and experience.
  • Experience in a healthcare, pharmaceutical, or biotechnology company.
  • Above average attention to detail, accuracy, and organizational, interpersonal and team-oriented skills.
  • Possesses a strong professional acumen when interacting with internal and external customers whether in-person, by telephone or in writing.
  • Ability to perform several tasks simultaneously to meet deadlines is necessary.
  • Experience directing and motivating staff in a matrix structure to meet deadlines while delivering high quality work in a dynamic environment.
  • Needs to be flexible, enthusiastic, highly adaptable, quick to assimilate new information, and demonstrates initiative as a team member and leader.
  • Demonstrates understanding of the workflow process, roles and responsibilities of multiple functional areas.
  • Excellent written and verbal communication, presentation and analytical skills.
  • Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail.
  • Willingness to embrace new technologies.
  • Must have valid, current driver's license and passport, as well as the ability to secure corporate credit card.
  • Ability to comprehensively manage required travel.
  • The drive for self-development, the ability to collaborate, and an action-oriented work ethic
As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated.

At Syneos Health, we believe in providing an environment and culture in which our people can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality of life balance.

Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Here, you’re essential in solving and executing against today’s toughest commercialization challenges facing the world’s leading healthcare companies. From the very beginning, you’ll be supported by team members who, like you, aren’t afraid to try something new. You'll gain exposure and work in a dynamic environment to create better, smarter, faster ways to get biopharmaceutical therapies to patients.


WORK HERE MATTERS EVERYWHERE | How will you accelerate biopharmaceutical commercialization?

Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)


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