Senior Quality Specialist

Company: Kelly Services
Location: Durham
Posted on: April 9, 2021

Job Description:

Kelly--is currently seeking a Senior Quality Specialist for a long-term engagement with one of our Global Pharmaceutical clients.--This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.RESPONSIBILITIES:

• Support the effective and compliant execution of tech transfer activities and development of necessary quality systems at the EM sites and associated off-site storage locations.
• Support site qualification activities and development of quality agreements in accordance with Company standards.
• Perform review and approval of equipment and facility qualification, technical documents, raw material specifications, analytical methods, and master batch records to ensure Company products/processes comply with cGMP requirements.
• Support regulatory submission activities, and lead inspection readiness activities in partnership to support global health authority approvals.
• Following successful tech transfer, support quality oversight for day-to-day production activities, including deviation and CPA management, escalation of critical issues, and change control.
• Monitor quality performance and proactively identify risks and mitigation plans through benchmarking and knowledge sharing.
• Influence and build relationship with internal and external partners to continuously enhance quality culture and business excellence.
• Interface with other functions (Operations, Planning, Technical Operations, Local Affiliates etc) to meet patient supply requirements
• Apply cGMP regulations and other FDA and international requirements to all aspects of the position.--QUALIFICATIONS:---------- Minimum education required for competent performance:
  • Bachelor's Degree with a concentration in engineering, science, or an equivalent technical discipline
  • Advanced degrees are a plus and may reduce the experience required--Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance:
    • Minimum of 8 years working in an FDA regulated environment--Equipment usage and abilities needed:
      • Experience in pharmaceutical aseptic manufacturing operations and quality assurance
      • Detailed knowledge of cGMPs related to pharmaceutical production
      • Strong interpersonal and written/oral communication skills
      • Ability to quickly process complex information and make critical decisions with limited information required
      • Experience in Vaccine Production/ QA
      • Proficient in applying process excellence tools and methodologies
      • Experience working with External Manufacturers or LabsPrevious experience with a CMOIdeal candidate will have a blend of QA, QC and Validation experience (QA and Validation are the most critical)"--Location:
        • Must be local to Durham, NC
        • UP TO 80% time to be on site at External Manufacturer possible.--Why Kelly--?Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]]

Keywords: Kelly Services, Durham , Senior Quality Specialist, Other , Durham, North Carolina