Job Listing: Quality Assurance Clearance I

Your Role:
Reporting to the Manager, QA BioServices Compliance, the QA clearance associate will be responsible for Device History Records (DHR)Master Batch Records (MBR) review, clearing and releasing products, writing queries and reports to databases for data reporting and analysis purposes, reviewing and approving deviations/investigations/CAPA/Out of Specification (OOS) for specific projects.

Primary Responsibilities:
Review completed Device History Records and Master Batch Records for completeness and accuracy prior to product release
Release/clear products in RenCS
Interact with other departments to coordinate the completion of necessary corrections to the Device History Records and related documents
Writes queries and reports to databases for data reporting and analysis purposes
Performs other projects as assigned by the department manager
Perform internal and external audits
Reviews and approves deviations/investigations/CAPA/OOS
Possible evening and weekend coverage

Your qualifications:
Bachelor's degree in the life sciences required (an AA degree with 3 years of relevant laboratory or manufacturing experience can be substituted for a Bachelor's degree)
Laboratory or manufacturing experience or internship preferred
Familiarity with regulated manufacturing processes
Background in biochemistry, molecular biology, and/or tissue culture practices
GMP compliance and Part 11 compliance knowledge preferred
Computer software skills including Microsoft Office, database and spreadsheet creation and maintenance, filing, organization, record keeping and planning skills, multiple projects, time management
Written and oral communication abilities to include accurate and legible documentation skills and the ability to work in a fast-paced environment.Need a team-oriented individual with independent work skills and a strong work ethic.

Required Skills for Quality Assurance Clearance I Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.