ROSEMARIE J. TAUTUA

• Led the implementation and review of customer complaints.
• Initiated and evaluated corrective measures.
• Write and review the disposition on non-conformances.
• Review return goods authorization.
• investigation and review final report of failure analysis.
• maintain quality charts.
• maintain calibration and maintenance of equipment.
• management representative during external agency audits such as FDA or ISO.
• management representative performing and monitoring internal quality audits.
• Assists in the implementation and reviewing documentation change requests
• Managed the hiring, training and evaluation of quality staff as well as assignment of project/duties.
• Responsible for implementing all elements of ISO and FDA requirements.
• Management representative during external agency audits such as FDA and ISO.
• Conducted all management review meetings according to schedule, documenting meeting minutes and agenda items as per approved procedures.
• Ensured quality through implementation and review of the corrective and preventive action program.
• Managed the scheduling, performance, and monitoring of internal quality audits.
• Ensured efficient handling of all customer complaints through implementation of standardized procedures.
• Responsible for implementation of documentation control system.
• Manage equipment calibration and preventive maintenance programs
• Implementation and reviews the disposition on non-conformances.
• Maintaining current with external regulatory requirements.
• Assists in reviewing all validations data, including sterilization and packaging validation, protocols and final reports
• Supervise the Quality Department and personnel.

Responsible for oversight of all aspects of Pharmacy purchasing including raw material procurement, inventory management, contracting and participation in and compliance with 503B FDA guidelines, CA state board of pharmacy regulations and 21CFR. Understanding and engaging in other areas of the company such as accounts payable, accounts receivable, Sales & Marketing, Customer service, Quality assurance tasks and bank reconciliations.

• Assisted in cGMP technical writing and records maintenance for SOP's and training materials.
• Purchased critical components, & drug ingredients.
• Managed all regulatory correspondence and licensing with FDA, DEA, and CA Board of Pharmacy
• Provided technical software installation, training, and trouble shooting.
• Created and developed all marketing presentations, folders, business cards, brochures, price lists, and mail chimp ads
• Devised strategies to optimize classified and unclassified areas.
• Sustained safety protocol to ensure proper, cost-effective and safe handling of equipment and material usage.
• Automated office operations, and managed client correspondence, stock record tracking, scheduling and data communications.
• Determined inventory goals, product stock and risk management objectives and oversaw techniques to maximize inventory.
• Lead and implemented inventory process, FIFO, lot tracking and recall reporting.
• Conducted vendor monitoring and supply chain management activities in compliance with internal logistics standards.
• Identified and rolled out both short- and long-term supply chain plans while optimizing procedures to decrease annual expenses.
• In charge of clinical trail accounts
• Conducted Shipping validations
• Setup up new customers
• Processed all customer orders
• Handle all customer complaints and concerns

• Ability to manage a high volume of accounts
• Work closely with pharmacists and use medication input software to safely and accurately dispense medication
• Efficiently answer multi-line phone system and process high volume of order requests from nurses and doctors in surgery centers and hospitals
• Pro-actively led and supervised pharmacy students as extern's
• Trained and supervised new employees
• Demonstrated proficiency in conducting scheduling and record management, adhering to licensure regulations and procedures
• Accurately pulled and labeled medication from shelves
• Receive and stock incoming supplies and maintain inventory
• Assist customers and staff by responding to questions and problems
• Price prescriptions
• Treated patients and customers in professional manner with respect courtesy; respected patients' rights to confidentiality
• Maintained inventory
• Ordered chemicals for pharmacy
• Received in Purchase Orders and double checked invoices to make sure quantity and pricing was accurate
• Worked closely with the pharmacist on checking in scheduled medications
• Logged inventory into Pk Software
• Made sure barcodes were accurate with the information that was scanned through Pk software.