Operations Specialist II

Duties & Responsibilities

• Ensures security and accuracy of inventory of materials and finished goods through transaction documentation and by conducting physical cycle counts and reconciliation of any discrepancies.
• Manage physical inventory within a Glovebox for raw materials, intermediate products, finished goods, analytical samples, and QA Retains.
• Perform small scale chemical reactions (dye labeling) for Quality Control testing.
• Fulfill internal requests for samples from inventory and perform sample preparation for quality testing.
• Perform Aliquoting/Vialing of air and water sensitive finished goods using manual and automated processes and equipment.
• Perform lyophilization of finished good products.
• Weight Checks and Packaging of air and water sensitive finished goods within a Glovebox.
• Prepare packaged products for QA inspection and shipments, including all required documentation.
• Cookordination with QC department to ensure timely testing and release of production materials.
• Accurately complete required documentation (batch records, data entry, etc.) on time.
• Manage the scheduling of service, preventative maintenance, and calibrations by coordinating work with contractors and laboratory associates and maintaining all associated equipment records including new equipment and retirement of equipment.
• Support document control and data archiving activities as assigned.
• Participate in non-conforming material, equipment out of tolerance, and customer complaint investigations.
• Promotes a safe work environment. Provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices.
• Participates in safety audits of safety equipment and laboratory processes.

Qualifications

• Typically requires a minimum of a Bachelor’s Degree in chemistry or biology with 2+ years relevant experience.
• Ability to follow standard operating procedures is essential.
• Experience with manual (pipette) and automated filling/dispensing is required.
• Prior experience in a chemistry lab is required.
• Experience working in a glovebox is preferred.
• Experience with Good Documentation Practices and ISO certified or regulated environment is preferred.
• Proficiency in MS Office Skills (Word, Excel, and PowerPoint) is required.
• Experience with SAP, BMRAM, and DocuNECT is preferred.
• Experience with root cause analysis/investigation preferred.