This Quality Associate position will be primarily responsible for Takeda's controlled form process for the Round Lake site. Additional responsibilities will include quality support of manufacturing batch documentation initiation, documentation review and reconciliation. Also, this role is responsible for identifying and implementing process improvements for the QA release department.
Executes Takeda Extensively Controlled Copy (ECC) procedures at the Round Lake site
Ensure controlled forms are properly reconciled
Authors deviations related to ECC process execution
Issue batch documentation to manufacturing
Manage controlled form distribution
Perform document archiving, including filing, cataloging, and categorizing documents per Global procedures
Identifies opportunities for continuous improvement; leads projects and implements continuous improvement initiatives
Communicates proactively with internal and external partners and management.
Assist the facility in preparation for quality audits and participate in corporate audits and external inspections
Assists department with monthly/quarterly Quality System data review metrics and reporting
Cross-trains and learns different positions in QA to fill in during vacations, leaves, and "all-hands-on-deck" situations.
Collaborates within and outside department on special projects, including moving various programs and paper-based processes to electronic formats.
Strong computer skills including Microsoft Word and Excel skills required. Exposure to and hands-on experience with a variety of applications is strongly desired.
Previous experience working with Veeva documentation management system preferred.
Previous experience working in a FDA regulated environment with knowledge of Good Documentation Practices and Data Integrity standards preferred.
Must be detail-minded and exact in terms of working with documentation
Strong drive to be an independent learner
Ability to work with minimal supervision in a dynamic environment while following written procedures
Must be organized and able to prioritize tasks
Ability to communicate efficiently orally and in writing with all levels of the organization
Must be flexible and adaptable to shift gears gracefully through changing priorities.
Cannot be allergic to Cephalosporin drugs
Ability to think on your feet
Must be willing to work a flexible schedule that may include weekends or evenings and be able to work overtime as needed
High School diploma or equivalent required; AA/AS degree preferred; 2-5 years of experience, preferably in an FDA-regulated environment (pharmaceutical or food industries)
Bachelor's degree preferred
Location and Salary Information: Â This job posting excludes CO applicants.
USA - IL - Round Lake - Drug Delivery
Internal Number: R0031018
About Biolife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.