Quality Control Associate Materials Management

SUMMARY : The Quality Control Associate for material management supports the Quality Control (QC) department by specializing in material and vendor management, with oversight of the department’s budget and the stability program. This role is responsible for maintaining inventory of laboratory supplies, chemicals, and reagents; coordinating with vendors to ensure timely procurement and delivery of materials while notifying QC personnel of any delays or discontinuations, monitoring department spending and ensuring Stability schedule, protocol, samples, and launches are maintained in compliance with internal and regulatory requirements. The position also manages preventive maintenance and calibration schedules for QC equipment, schedules and documents servicing activities, prepares and tests reports for regulatory bodies, and ships test samples or reagents to necessary vendors with proper documentation. Additionally, the Quality Control Associate I serves as back-up for the QC sample room and provides support for other QC administrative functions, including documentation, filing, and record management.

RESPONSIBILITIES : •    Material & Vendor Management: o    Review and maintain inventory of laboratory supplies, chemicals, and reagents to support laboratory operations. o    Coordinate with vendors to ensure timely procurement and delivery of materials, and promptly notify QC personnel of any delays or discontinuation of materials from vendors. o    Monitor and track department budget related to materials and supplies to ensure spend is staying within allotted budget. •    Equipment Maintenance: o    Maintain preventive maintenance (PM) and calibration schedules for QC equipment (e.g., pipettes, thermometers, and other departmental instruments). o    Schedule and document equipment servicing and calibration activities. •    Regulatory Reporting & Testing: o    Prepare test reports for submission to regulatory bodies, ensuring accuracy and compliance with required standards. o    Coordinate and track the shipment of test samples or reagents to vendors or external laboratories, ensuring clear communication, proper documentation, and strict chain of custody throughout the process. •    Stability Program Management: •    Establish the annual stability schedule •    Completes launches according to the plan to ensure on time testing •    Stability sample management •    Authoring of stability reports •    Ensuring all internal and regulatory commitments associated with the stability program are met. •    Quality Control Administrative Support: o    Serve as back-up for the QC sample room, assisting with sample receipt, storage, and tracking as needed. o    Provide support for other QC administrative functions as needed, including documentation, filing, and record management. EDUCATION AND EXPERIENCE : •    BA/BS degree in scientific discipline or business with 0-2 years experience  (experience in SAP/zLIMS highly desired)  or 6 years relevant experience •    Demonstrated ability to interact positively with all levels of colleagues. •    Strong communication (oral and written), interpersonal, and team/group interactive and leadership skills.   •    Strong commitment to product quality, customer service, and continuous improvement.  TECHNICAL SKILLS REQUIREMENTS : Proficient in Microsoft Word, Excel, Powerpoint, Outlook, etc.     Experience with 9CFR & EU regulatory requirements.  Experience with outlines of production and special outlines. Experience maintaining departmental budgets and tracking inventory using relevant management systems. SAP/ZLIMS/Veeva Vault/ ETS PHYSICAL POSITION REQUIREMENTS   • Must be able to walk, sit, or stand for long periods of time.  • Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently. • Must be able to work scheduled 40 hours