Operator Machine

Jose F. Herrera

** *** ***. ******, **.*****

Phone: 732-***-****(Cell)

**********@*****.***

Manufacturing Coordinator

Objective

To obtain a position in Pharmaceutical or Production Co. that allows me to utilize my professional experience.

Summary of Qualifications

Over 20 years of experience in Pharmaceutical Manufacturing Technical operations with specialized expertise in Aseptic Operations.

Skilled in identifying and diagnosing problems and in resolving them by implementing effective solutions.

Plan, prioritize and work efficiently to ensure set deadlines are met.

Function as an effective team leader who communicates clearly within the team and between other teams.

Knowledge of Quality Operations and experienced in working in FDA regulated environment.

Full knowledge of cGMP’s [current Good Manufacturing Practices]

Professional Experience

DPT Labs, Lakewood, NJ Dec 2012-Sep 2020

Manufacturing Coordinator

Created a daily schedule of 45 to 50 employees (with different type of experiences and job titles) to meet the company production for the day.

Coordinated with other departments in making sure that we had the proper Batch record, components and product release.

Place order for supplies require to meet daily activities.

Train new personnel on proper vial technique in order for them to qualify as vials inspectors.

Ensure efficient operation of equipment by calling for repairs, facility maintenance requests; evaluating new equipment and processes.

Responsible for in-process review of documentation in accordance with good documentation practices and follow up on corrections.

Immediately address and report to the Supervisor any behavior or practice that is not cGMP compliant. Maintain knowledge of cGMP by attending required training sessions.

Participate in team efforts to improve work environment, product quality and other initiatives identified as being beneficial to the company.

Meet regularly with production personnel to communicate company information and review progress/performance against department goals and action plans.

Successfully perform all functions of a Gown Qualified Operator. Coordinating all manufacturing activities inside the cleanroom as directed by the supervisor.

Train new employees in clean room behavior, gowning requirements and documentation practices.

Genzyme Biosurgery, Ridgefield, NJ Jul 1998- Oct 2012

Senior Aseptic Technician

Conducted initial batch record review and inspected the area prior to start up to verify that clean-up activities were performed.

Processed and Cross linked Hylan Gel (B-10) using chemical such Vinyl Sulfone, Sodium Hydroxide, Saline solution. Processed hylan fluid (A-10).

Compounding hylan gel (B-10) with hylan fluid (A-10) to make final product hylan G-F20 bulk.

Weigh, measure and check raw materials to ensure batches manufactured contain proper ingredients and quantities.

Set up Cozzoli filling machine, Inova syringe filler-RAB (H3-5V) and Inova syringe filler (H6).

Performed filling operations (Syringes 2.25ml and 10ml) using INOVA/C0ZZOLI filling machine.

Monitored air quality during product exposure by using TSA (Trypticase Soy Agar Plate) SAB (Sabouraud Dextrose Agar Plate) and Met One air particulate device.

Performed complex set-up of varies equipment such as Precipitation reaction vessel, 50-liter vessel, 100-Liter vessel, and Homogenizer.

Performed cycle count, reconciliation and CIP (Clean in Place) and SIP (Steam in Place).

Experienced with aseptic equipment’s such as Sterilizer, Autoclaves (SBM, Fade Geri).

Experienced in Aseptic environment class 100 and 10000 clean room areas.

Criterion Sciences (formerly Stephens Scientific) Jan 1992- May 1998

107 Riverdale Rd, NJ, 07457

Line Operator

Production line set-up and area control.

assigning of worker’s responsibilities.

Write standard Operation Procedures (SOP).

Autoclaving, bubble-point testing and inspection of filters.

Prep and maintenance of assigned tanks and filling equipment.

Batch Mixer (products shown below)

Modified Rinse, Modified Buffer.

Hema-Clean Detergent, Hematology Detergent and Diluent Plus 3.

Decal and Decal F solutions.

Glucose Tolerance Drink.

Education/Training

Attended New Jersey Institute of Technology (NJIT) 1985-1989 for business management.

High School diploma from Vailsburg High School in 1985.

Certifications: Hazmat training (24 hours training course). Member of the Spill Respond Team for eight years.

Equipment: Full Mask Respirator, Self-Contain Breathing Apparatus (SCBA), Auto Clave, Girton Washer, Homogenizer, P.H meter, CIP/SIP Skid, 50L Vessel, 100L vessel, 150L vessel, Inova/Cozzoli filling machine and E-Beam machine.

Other Skills: MS Word, Excel, and Outlook

Foreign Languages: Fluent in Spanish

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