Responsible for all Quality Assurance related aspects of material handling, storage, shipping and control, and all associated documentation. This position may also be cross-trained on Product Disposition and Regulated Document/Training functions.
Quarantine materials, inspect shipments, examine Certificates of Analysis, review test results, determine release status, and manage all raw materials documentation.
Preparation and circulation of controlled documents (e.g., specifications, labels).
Stability Data Review.
Generation of associated reports.
Trains new and existing employees in QA raw material release.
Conduct changeovers in production area as required.
Participate in audits, investigations, and other projects as appropriate.
Prepare, review, and revise SOPs and MSSs as required.
Bachelor’s degree in science or equivalent is required; Biology/Chemistry preferred, with 1-3 years of experience in the biotechnology, pharmaceutical, or clinical (GxP) industry; or equivalent combination of education and experience.
Experience in Raw Material Release and Clinical Shipment functions strongly preferred.
Excellent written and verbal communication skills required, including Responsible Business Communication.
Scientific writing experience preferred.
Superior attention to detail, organizational skills, and ability to handle multiple tasks in a timeline-driven environment necessary.
Strong customer service philosophy required; experience a plus.
Must be proficient with MS Office applications.