Rocio Pimentel

Verified line cleaning and granted timely release approval.

Monitored packaging and inspection operations ensuring adherence to specifications and procedures.

Prepared samples of packaged products for QC testing and stability.

Ensured all required data entries in packaging logbooks were complete and precise.

Executed and validated documentation for packaging qualification.

Inspection of final finished package prior to end of packaging run and before transfer to warehouse.

Notified QA management of any quality or safety.

knowledge of cGMPs related to US FDA manufacturing and packaging environments.

• Inspection of production line.
• Verifies all raw material and components.
• Reviewing documents and batch records.
• Monitored all inspection and testing equipment met valid calibration date.
• Identified unsafe working practices.
• Maintained current with SOPs, cGMPs and GMPs.
• Responsible for gathering samples for multiple products.
• Assured quality of finished good product met requirements.
• Completed quality inspection documents as needed, based on product requirements.
• Verified bulk and materials assigned to production line.
• Sampled product for proper weight as per sample request.
• Conducted hourly inspection of finished product using calipers, scales, test tube and test uni doses. As per products.
• Completed batch record documentation.
• Learned and adapted quickly to new technology and software applications
• Gained extensive knowledge in data entry, analysis and reporting
• Paid attention to detail while completing assignments
• Demonstrated leadership skills in managing projects from concept to completion
• Reported repeated issues to supervisors and other departments, collaborating to identify issue roots and rectify problems.
• Communicated with production team members about quality issues.

• Complete daily visual audits of Aseptic Behavior inside the core during setup, formulation, fills, and sanitization processes.
• Communicate openly to all personnel in the aseptic core to provide mentoring regarding observed performance.
• Take immediate action when non-compliance and/or undesired behavior by personnel in the facility is observed.
• Provide corrective action training based on visual audits by providing immediate feedback.
• Partner with Operations/Quality/Training Leadership to make recommendations for enhancements to aseptic process.
• Complete regular inspections of the physical conditions of the aseptic core.
• Review aseptic technique associated with media fills and helps complete documentation and final unit count verification as necessary.
• The ability to aseptically gown and work in an aseptic manufacturing environment.
  Daily presence in the Aseptic Core is required.
• Responsible for training personnel in Aseptic Techniques and processes.
• Assumes additional duties and responsibilities as assigned.

• Perform operations pertaining to machineries for filling and packaging items.
• Regulate machine flow.
• Reset machines in event of errors along with fixing them if malfunction occurs.
• Identify and removing damage packages from assembly line.
• Weight and inspecting products to ensure they conform to standards.
• Monitor production line and fix problems occur due to pile-ups and jams.
• Managing all aspects of production line and supervising employees.
• Making out certain employees following company rules and safety standards.
• Drafted reports and monitored progress.
• Working in compliance with cGMPs and SOPs.
• Perform cleaning, set-up and procedures according to requirements of production and packaging.
• Assisted in training new employees and implementing procedural changes
• Coordinated staff, parts and process flow to minimize work in progress, eliminate shortages, and maximize productivity
• Collaborated with manager on performance-related issues and employee performance reviews
• Safely operated fillers machine, sealers and case packer to avoid accidents and mishaps
• Provided and promoted solutions to eliminate reoccurring problems
• Collaborated with other departments to establish smooth operations and encourage teamwork
• Strong knowledge of filling machinery such as: Linoline by Optyma, Kugler by Optyma for nasal spray, Cozzoli for otics drops, Orics for unid dose, IWKA for semi solid (cream and oiment).