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Quality Assurance Specialist

Kelly Scientific Resources Austin Full-Time
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Kelly Services is looking for a Quality Assurance Specialist in Austin, TX 12-month contract to hire Pay rate negotiable on experience. Description: Responsibilities: 

The primary objective of this role is to support the Quality Assurance Manager in conducting a thorough quality review of change request packages pertaining to life cycle management controlled under the scope of the corporate process (such as specification, test method and manufacturing process changes). The role is required to provide prior approval of changes to products and process to route for review by Change Control Review Board (CCRB). Responsibilities also include conducting the post verification check for completion of the implementation plan. The role requires delivering a quality content review of changes while being a part of complex cross functional teams in a timely manner. 

• To conduct a thorough but efficient content review of the description, reason and justification of the change, and to ensure that the attached documents adequately support the proposed change. 
• To conduct a thorough but efficient review of cross functional impact assessments and assist initiator in determining that all impacted areas, processes, documents, validation and equipment are identified by the initiator. 
• Responsible for ensuring that the implementation plan aligns with the impact assessment. 
• Responsible for assigning the subject matter experts (business functions and sites) who perform the impact assessment on the change and who review the implementation plan (action items and target date) to execute the change; this position will function as the subject matter expert (SME) for the Change Management Procedure. 
• Responsible for providing recommendation to the Change Management Coordinator after the initial quality review of impact assessment and implementation plan. 
• After the implementation is complete, prior to the closure of change control, review the objective evidence for each of the identified items in the implementation plan and verify that the intended change was completed. When all of the items identified in the implementation plan are completed, responsible for the approval of the change plan verification. 

Experience & Knowledge: 

• Requires a Bachelor's degree in scientific field or equivalent pharmaceutical experience. 
• Very good understanding of manufacturing operations for drugs. 
• Familiar with global regulations on drugs and validation/qualification requirements. 
• Excellent verbal and written communication skills 
• Excellent time management and organizational skills. 
• 0-3 years in managing/initiating changes associated with processes, products, equipment, facilities and systems at the manufacturing site level for drugs or have worked in audit functions of the quality organization. 
• Prior experience in a role providing technical experience through analytical chemistry/microbiology/biology testing. 

• Prior experience in a Quality Function preferred. 
• Prior experience with sterile drugs preferred, but not required.

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit URL blocked - click to apply and connect with us on URL blocked - click to apply, URL blocked - click to apply and URL blocked - click to apply.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. URL blocked - click to apply


Skills required

Sample Procedure
Quality Assurance
Performance Testing
Perform Inspection
Total Quality Management
Provide Technical Guidance
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Job ID: US41L7SS_BH1582351


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In a recent study, one-third of large companies predicted contingent workforce growth of 50 percent or more.* Kelly Scientific Resources® can help you be a part of this contingent workforce growth opportunity.

Kelly Scientific Resources is a specialty service of Kelly Services®. As the world's largest provider of HR solutions to the scientific community, Kelly Scientific Resources is focused exclusively on placing skilled scientific professionals in contract, contract-to-hire, and full-time science jobs across a full spectrum of related industries and disciplines, including:

  • Biomedical
  • Biotechnology
  • Chemical
  • Clinical Trials / Clinical
  • Clinical Research
  • Consumer Products
  • Cosmetics
  • Drug Discovery and Safety
  • Environmental Health
  • Food Science
  • Health Physics
  • Laboratory
  • Pharmaceutical
  • Production and Manufacturing
  • Quality Assurance and Control
  • Research and Development

Kelly Scientific Resources employees work more than 7 million hours in positions ranging from clinical research associates to molecular biologists to biochemists—from entry level to Ph.D.

It all began when William R. Kelly—founder of the temporary staffing industry—established Kelly Services® in 1946. The company's traditional expertise started with office services, call center, light industrial, and electronic assembly staffing. Through the years, we expanded our expertise and established a proven record of successfully matching job seekers to opportunities in disciplines such as science, engineering, law, education, healthcare, IT, and finance. As a Fortune 500® company, Kelly® has evolved into a global workforce solutions leader, making employment connections for nearly half a million people around the world every year.

Since our founding, we have embodied the true spirit of social responsibility. Our character and values resonate through our culture. Inherently—through our core business focus—we seek to improve the quality of life for our employees, their families, and their communities, as well as society at large. We embrace the role we play and the value we contribute to society—whether ensuring equal opportunity to employment, promoting safer workplace conditions, advocating for healthcare reform, or adhering to sustainable business practices.

Together with our employees and our customers, we will continue to work toward ensuring that our legacy will remain strong for generations to come. For more than 60 years, people have trusted Kelly Services to help them reach their career goals. We are your proven link to employment opportunities that will pave the way for a successful future. Whoever and wherever you are—and with the right skills and attitude—Kelly can help you find a job, expand your career, and build your future.

*According to “The Emerging New Workforce,” a 2009 report by Littler Mendelson, P.C., an employment and Labor Law solution firm.

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