Kelly Services Pharma Manufacturing Consultant (Short Term) - FDA - Virtual in Bethesda, Maryland
Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are seeking an individual to work as a Pharma Manufacturing Consultant (Short Term) at the Food and Drug Administration.
TASKS/SERVICES. The contractor shall:
Review Manufacturing Site Assessment Tool and validate assessment approach with the team
Conduct Assessment of supplier sites and assign ratings based on analysis of interviews and evidence presented
Develop an assessment report and provide feedback to the supplier sites
Mentor other assessors
REQUIREMENTS. The contractor must have:
Bachelor’s Degree in Sciences (Microbiology, Biology, Biotechnology, Chemistry); Master’s or Ph.D preferred
15+ years of relevant experience to include but not limited to:
GMP audits of Small Molecule API Manufacturing facilities in US and abroad (EU, India, South America, etc)
Providing consultation and technical solutions to remediate GMP deficiencies in pharmaceutical manufacturing
Preparation and execution of Quality Planning and Quality Management Reviews
Knowledge of cGMPs, ICH Q10 and ICH Q7
Interfacing with Internal and External Auditors, marketing, customers and regulatory authorities
Perform Risk Assessments/ Due Diligence Assessments/Gap Assessments on Quality Systems and produce reports
Quality Culture assessment and Continual Improvement initiatives
Current with pharmaceutical industry trends and best practices in mature Quality organizations, especially those in API manufacturing.
Knowledge or experience in corporate operations (planning, capital investment planning, business metrics, market intelligence etc)
Availability to support virtual assessments of foreign sites during shift hours. Weekend and overnight availability may be needed depending on site availability schedule.
Excellent written and verbal skills (in English) including proficiency with MS Office suite
Collaborative approach working within a team and external stakeholders.
Other duties that may be assigned during the project execution
Availability to periodically attend in-person meetings (pandemic restrictions permitting) in Fairfax, VA preferred.
PLEASE APPLY ONLINE
When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time.
Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you aren’t contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.
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Why Kelly ® ?
Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly® Government offers a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technical, professional, and administrative support roles. Our experts will find you the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. It’s just another way we make the job search work for you.
About Kelly ®
Kelly connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. We’re always thinking about what’s next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 500,000 people around the world, and we connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice.
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