Staff QA Specialist II

Company: Advanced Clinical
Location: Durham
Posted on: May 25, 2023

Job Description:

OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Staff Quality Assurance (QA) Specialist II in Durham, North Carolina. This lab-based onsite role will function within the Quality Assurance Unit (QAU) and participate in the conduct of nonclinical laboratory investigations of medical devices and materials in accordance with GLP regulations and the client's internal Quality System. Your work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

• Interact with both internal/external stakeholders to ensure compliance of preclinical studies to the GLP regulations (21 CFR Part 58) and internal procedures
• Participate in the development, implementation, and maintenance of various aspects of the internal Quality System
• Create and review documents (SOPs, Procedures, Methods, Protocols, etc.) in overall support of continual quality improvement
• Serve as lead for the QAU for multi-site studies and work with QA management to ensure there is adequate QAU coverage for all aspects of a GLP study
• Ensure training is performed and documented to maintain compliance with the Quality System and regulatory requirements
• Accompany representatives from sponsoring organizations/government regulatory agencies during site audits
• Perform GLP and Quality System training
• Maintain the Master Schedule
• Collaborate with staff to identify, evaluate, and recommend solutions to audit findings during the performance of quality audits
• Assist in the management of the supplier audit and approval system, including setting audit dates with suppliers and performing audits
• Collaborate with managers, scientists, and Quality Assurance personnel to develop process improvements to enhance testing and workflow efficiency
  EXPERIENCE
  
  • Minimum of 5 years of experience with large animal GLP testing required
  • Understanding of application of Quality System Standards to assigned Quality system area
  • Knowledge of Quality Systems Regulatory requirements and application to Company/Unit requirements
  • Strong knowledge of 21 CFR Part 58 and Preclinical Functionality Testing including the design of compliance strategies to support successful regulatory submissions
  • Ability to work successfully independently as well as part of a team
  • Good verbal and written communication skills
  • Excellent organization and the ability to adapt rapidly to changing priorities in a high-volume scientific testing laboratory while managing multiple projects and programs simultaneously
  • Travel required - to audit suppliers and site locations for audit-related site visits
    EDUCATION
    
    • Minimum of Bachelor's Degree in scientific discipline requiredTo be a best-fit your strengths must include:
      
      • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
      • Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
      • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
      • Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
      • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
      • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.About Advanced Clinical
        Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each opportunity with foresight, character, resilience, and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions
        Regarding your application
        Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
        Equal Employment Opportunity
        It is Advanced Clinical's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

Keywords: Advanced Clinical, Durham , Staff QA Specialist II, Other , Durham, North Carolina