Sr Quality Assurance Specialist - Bloomington, IN
Kelly is currently seeking a Sr Quality Assurance Specialist for one of our Global Sponsor Clients to work at a site in Bloomington, IN. This role is a full-time and projected for 1 year or longer. We are offering our enhanced benefit package options. As a Kelly employee within this group, you will be eligible for Medical, Dental, 401K and a variety of other benefits options to choose from. This includes paid time off, including holiday, vacation, and sick/personal time unless told otherwise.
If you're looking for an opportunity to work on a world changing Vaccine in the COVID-19 space, then this job is for you!!
- Support the effective and compliant execution of tech transfer activities and development of necessary quality systems at the manufacturing 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 with external manufacturing site and our client to support global health authority approvals.
- Following successful tech transfer, support quality oversight for day-to-day production activities, including deviation and CAPA management, escalation of critical issues, and change control.
- Monitor external manufacturing 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.
- Ability to work from home 20% depending on activity needs
Experience / Knowledge Required:
- Bachelor's Degree with a concentration in science, or an equivalent technical discipline
- Minimum of 5 years working in an FDA regulated environment
- 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
- Validation quality assurance experience is required
As a worker today, it's up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what's next is what we're all about. We know what's going on in the evolving world of work—just ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.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.
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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