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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)

  • Supplier Qualification

  • 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.

As a specialty talent company, Kelly is committed to doing the right thing for our talent and clients. We stand up for equity, inclusion, fair treatment, and opportunity for all as these build the foundation of our Talent Promise. With a focus on safety, value, well-being, investment, and opportunity, Kelly’s Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover what’s next.

It is obvious things are different than they were just a few months ago. Kelly is at the forefront of ensuring the safety of our employees in this new working environment. Be well and stay strong.

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.

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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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