Quality Assurance Control

Hala Al Ahmad

** ********** ***** • Lincoln Park, NJ 07035 Home: 973-***-****

Email: ********@*********.*** Cellular: 862-***-****

Summary

Dedicated professional with a proven track record in Pharmaceutical and Biopharmaceutical production as well as other critical areas. A motivated quick - learner who is interested in a continued challenging career in Biotechnology or Pharmaceutical production where my skills can be used to enhance the already existing expertise of a professional organization.

Experience

Synerfac Parsippany, NJ (LTS Lohmann Therapy System) 2013- Present

Quality Assurance Sample Technician

Aseptic Technic sampling of incoming raw material.

Incoming inspections using physical and visual test methods and provide reports.

Perform correct status of labeling.

Perform AQL testing as per approved procedures and provide report.

Provide daily calibration and maintenance of instruments and equipment.

Actavis Pharmaceuticals, Elizabeth, NJ 2013-2013

Analytical Development Sample Coordinator

Receipt/Log-in of DEA controlled and non-controlled Substances.

Dispensing of DEA Samples.

DEA sample waste management.

Coordinate inventory of DEA samples.

Coordinate DEA sample destruction.

Coordinate and controlled DEA inventory.

Actavis Pharmaceuticals, Elizabeth, NJ 2007- 2013

Quality Assurance Sample Technician

Sampling of incoming control and non-controlled raw materials.

Sampling of incoming packaging and labeling components.

Inspection and proofreading of labeling components.

Perform testing of packaging components.

Labeling and controlling status of incoming materials.

Filling of QA retain samples and filling of sample request.

Actavis Pharmaceuticals, Elizabeth, NJ 2006 - 2007

Pharmaceutical Operator

· Operate compression machinery for tablets.

· Performed all job functions with strict adherence to cGMP’s and FDA regulations

· Adhere to standard operating procedures (SOP).

· Complete batch records in a timely manner.

Niagara Conservation Corp., Cedar Knolls, NJ 2006 - 2006

Quality Control Technician

Inspect incoming shipments according to written quality control procedures and ASME & ANSI standards.

Inspections include flow rate validation, MaP testing protocols for performance, timer validation, and visual inspections.

Enzon Pharmaceuticals Inc., South Plainfield, New Jersey 2004 - 2006

Assignments as Technician 2

Performed Compounding duties for bulk formulations.

Performed Batch Record Review.

Performed CIP sanitization.

Set-up Ultra filtration, Diafiltration units.

Performed all job functions with strict adherence to cGMP’s and FDA regulations.

Monitor WFI system and Pressure Differentials.

Operate Autoclave equipment.

Operate Gruenberg oven.

Aseptically sanitize equipment at the completion of each operation.

Aseptically sanitized class 100 and class 10,000 areas as needed. Responsible for making accurate dilutions of cleaning solutions and ensuring proper application.

Aseptically gowning qualified and retest on a semi-annual basis.

Responsible maintaining training on and demonstrating efficiency on multiple SOPs.

Responsible for set-up and operate label, packaging and coding equipment.

Qualified as an inspector of filled and capped vials for defects in the aseptic core and packaging lines.

Pharmaceutical Tech/Materials Coordinator

Responsible for coordinating activities in the Production Materials area.

Supplied raw material excipients and drug substance for batch processing.

Perform routine inventories and re-order of supplies when needed.

Coordinated the disposition of rejected materials and components.

Coordinate and performed sanitization of all supplies, packaging components and equipment prior to sending to cleaned and controlled areas.

Organon Inc., West Orange, New Jersey 2002 - 2004 Pharmaceutical Tech/Materials Coordinator

Assignments as Materials Coordinator

Responsible for coordinating activities in the Production Materials area.

Supplied raw material excipients and drug substance for batch processing.

Adhere to cGMPs, OSHA policies, and internal company safety policies and procedures.

Perform routine inventories and re-order of supplies when needed.

Perform periodic cycle counting to ensure an accurate inventory

Coordinated the disposition of rejected materials and components.

Coordinated and monitored inspection of glass vials prior to issuing to the product teams.

Used first-in-first-out (FIFO) procedure for supply deliveries.

Coordinate and performed sanitization of all supplies, packaging components and equipment prior to sending to cleaned and controlled areas.

Assignments as Technician 2

Responsible for packing over 100,000 vials of product on a daily basis in a class 100,000 environment. Performed routine inspections and evaluation of vials to remove any rejects

Aseptically sanitize equipment at the completion of each operation.

Aseptically sanitized class 100 and class 10,000 areas as needed. Responsible for making accurate dilutions of cleaning solutions and ensuring proper application.

Aseptically gowning qualified and retest on a semi-annual basis.

Operated several vial washers using filtered WFI. Responsible for making minor adjustments as needed.

Operate post-sterilization vial dryer. Packed vials into shipping containers. Responsible for correct labeling and accountability of rejects

Perform volume checks on the filling line. Responsible for reacting to volume related issues and communicating problems to filling technicians and the supervisor. When Computerize Free-weigh system is not working, performed manual weighing and calculations of volumes.

Responsible maintaining training on and demonstrating efficiency on multiple SOPs.

Hoffmann-La Roche Inc., Nutley, New Jersey 1999-2002

(Production Specialist)

Operated packaging equipment (i.e. Jones Cartoner, West Capper, Omega Bundle Wrapper).

Qualified as an inspector of filled and capped vials for defects in the aseptic core and packaging lines.

Received gown certification for entry into class 100 aseptic areas.

Prepared germicidal detergents solutions and filtration of these solutions.

Performed decontamination of aseptic as well other controlled areas.

Prepared, assembled and tested clean compress air membranes and filters.

Performed environmental monitoring of decontamination personnel.

Supervised operation of the Cozzoli vial washer and depyrogenation tunnels.

Performed Batch Record Review

Performed all job functions with strict adherence to cGMP’s and FDA regulations.

Education

High School Graduate

Medical Office Assistant Diploma

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