Kelly Services is looking for a Quality Assurance Specialist in Austin, TX
12-month contract to hire
Pay rate negotiable on experience.
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.
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.
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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
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