Quality Assurance Specialist

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  • Location:

    Rockville

  • Job type:

    Contract

  • Job ref:

    337935

  • Published:

    about 1 month ago

  • Expiration date:

    07/23/2021

  • Start date:

    ASAP

Job Summary:

Signature Consultants is looking for a Quality Assurance Specialist for an opportunity with a client located in Rockville, MD.

Responsibilities:

  • Conducts activities and interactions consistent with organizational values and behaviors and in compliance with the Code of Conduct and supporting policies and standards relevant to the role
  • Completes all required training on the Code of Conduct and supporting policies and standards within established timeframes
  • Reports potential issues of non-compliance
  • Serves as a knowledge resource to staff with a deep understanding of organizational global and local procedural documents and local implementation of objectives, policies, processes and procedures and regulatory requirements, guidelines and obligations relevant to clients for medical devices and delivery systems (e.g. injectables, inhalers)
  • Conducts a range of QA activities of multifaceted scope and complexity on an individual basis working within established timeframes ensuring compliance with global and local procedures, policies, processes and guidelines
  • Performs the tasks of the Client process to ensure consistent, clear, effective, and timely identification and communication of all clients to the appropriate investigation supply sites
  • Responds to supply site inquiries regarding PQCs and follows up on supply site inquiries with customers as needed
  • Manages customer interactions to successful resolution
  • Obtains pertinent customer information and record customer interactions in appropriate systems
  • Meets AZIC quality and customer satisfaction standards
  • Maintains a high level of understanding of relevant quality systems

Essential Qualifications:

  • Qualified to degree level preferably in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering or an equivalent pharmaceutical industry quality assurance background
  • Minimum of 2 years of quality assurance experience, to include knowledge of cGMPs, quality systems, and the pharmaceutical supply chain environment including a solid understanding of FDA and other Health Authority regulatory requirements, guidance and obligations
  • Proven analytical skills
  • Proven leadership skills
  • Demonstrated ability to work independently and effectively in a cross-functional team environment with ability to work across cultures
  • Demonstrated ability to manage multiple competing assignments and timelines
  • Fluent in English language with excellent communication skills, both oral and written
  • Demonstrated ability to influence whilst maintaining independent and objective views
  • Demonstrates ability to maintains high ethical standards, including a commitment to organization values and behaviors
  • Detail oriented
  • Computer literate

Desirable Experience:

  • Advanced degree in Quality Assurance/Regulatory Affairs and/or professional certification (project management, Lean Six Sigma, American Society for Quality (ASQ) Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/ Organizational Excellence, or Society of Quality Assurance (SQA) Registered Quality Assurance Professional (Minimum 3 years of Quality Assurance auditing experience)
  • Previous experience in a Lean, process-centric organization with emphasis on continuous improvement
  • Extensive experience in a pharmaceutical quality assurance environment
  • Experience with medical devices and delivery systems (e.g. injectables, inhalers)
  • Multi-site / multi-functional experience
  • Project management expertise
  • Previous experience in a call center environment
  • Demonstrated ability to lead without authority

About Signature Consultants, LLC

Headquartered in Fort Lauderdale, Florida, Signature Consultants was established in 1997 with a singular focus: to provide clients and consultants with superior staffing solutions. For the ninth consecutive year, Signature was voted as one of the "Best Staffing Firms to Work For" and is now the 14th largest IT staffing firm in the United States (source: Staffing Industry Analysts). With 28 locations throughout North America, Signature annually deploys thousands of consultants to support, run, and manage their clients' technology needs. Signature offers IT staffing, consulting, managed solutions, and direct placement services. For more information on the company, please visit www.sigconsult.com. Signature Consultants is the parent company to Hunter Hollis and Madison Gunn.

EEO Employer

Signature Consultants is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Signature will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or 888.838.1020.