Darlene Contreras Rivera

Urb. Los Flamboyanes, Calle Higüero 139 Gurabo, P.R. 00778

Tel. 939-***-****

Email: ad4v40@r.postjobfree.com

Summary of Qualifications

Manufacturing Operator and Team leader with over 17 years of expert experience executing manufacturing/packaging operating steps on batches of products utilizing the proper equipment and following instructions defined in applicable safety policies, procedures, and Batch Production Records in either electronic or paper format. The operating steps include equipment preparation for manufacturing, sanitation procedures, and packaging processes, set-ups as well as the operation of equipment located within a designated work center operation of various pieces equipment located within a designated work center. Computer literate skills: Microsoft Office (Word, Excel, Power Point, Outlook). Ability to perform multiple projects and responsibilities in a high-pressure environment with minimum supervision. Good verbal and written communication skills (English and Spanish). Areas of Expertise

Provided training and coaching to operators as well as Technicians; GMP’s and Regulatory issues; Participate in Factory Acceptance test for new equipment acquisition, Packaging Technology, Process validation and Technology Transfer. Professional Experience

Amgen, Juncos PR

Packaging and Inspection team leader October 2005 – January 2023

• Support the front-line manager (supervisor) with the coordination of the team and leading the packaging line resources.

• Under limited supervision, perform equipment setup, operation, troubleshoot to meet all standards for safety, quality, and efficiency.

• Perform basic, routine manufacturing process operations such as dispensing of raw materials, material reconciliation, line clearance, basic analytics, and record transactions.

• Assist in the review of documentation for assigned areas (i.e., procedures, logs, area audits, and batch records)

• Assist as equipment Subject Matter Expert (SME) in training resources on manufacturing tasks and equipment use.

• Ensures components and products are available for continuous operation.

• Carries out equipment inspections and generates emergency, corrective, or preventative work orders as needed in the Maximo system.

• Troubleshoot and identify potential solutions for equipment or operational errors, safety issues or general operating inefficiencies within the production processes.

• Partner with cross-functional teams to help drive improvement opportunities.

• Able to use computer systems to support material inventory system (SAP transactions) and electronic batch records.

• Oversight of equipment/process validation protocols independently.

• Safely follow standardized operating procedures including material handling, record keeping, assembly and packaging. Must follow Good Manufacturing Practices (GMPs).

• Support Operation in Non-Standard shift that includes weekends and /or holidays as determined by business skills.

Garabatos, San Juan, PR

Customer Service February 2023 – November 2023

• Cashier

• Hostess

• Waiter

• Bartender

Education

High School Diploma (Estudios Libres) - 1999

San Juan, Puerto Rico

Training

GMP Certification

Equipment and Operation logbook

EHS, FDA, Regulations

EBR and SAP

Microsoft Office

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