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Quality Assurance Senior Associate

Louisville, KY
Top 3 Must Have Skill Sets:
    
GMP experience
• Quality Assurance or manufacturing experience
•Pharmaceutical or medical device industry preferred
• Good written and oral communication

Description:

Requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment. In accordance with applicable law, will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to its operations, or its staff.

***Onsite***

Committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Responsibilities:
• Perform receipt, manufacturing, storage, distribution, and Facilities & Engineering documentation review to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
• Perform cGMP process, procedure, document and record review, approval and tracking, including but not limited to Deviations, CAPAs, Change Controls, and Validations. May also support execution of these tasks.
• Perform routine Quality Assurance assessments of site operations and provide direct oversight.
• Support Labeling and Packaging Operations including incoming raw material inspection and manufacturing oversight.
• Represent the Quality Unit during audits and inspections as needed.
• Support internal/external audits and inspections as part of the audit/inspection team as needed.
• Perform additional duties as specified by management

Basic Qualifications:
• Master’s degree and 1 year of Quality experience
• Bachelor’s degree and 2 years of Quality experience OR
• Associate’s degree and 6 years of Quality experience OR
• High school diploma / GED and 8 years of Quality experience

Preferred Qualifications:
• Ability to interpret and apply cGMP and GDP
• Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry
• Good written and oral communication

"This posting is for Contingent Worker, not an FTE"

 

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